UMDNS
CODE
UMDNS TERM English
10003Binders,Abdominal
10012Testers,Achilles Reflex
10014Acupuncture Kits
10024Adaptometers
10025Adenotomes
10026Adhesive Strips
10028Adhesive Strips,Hypoallergenic
10029Adhesive Strips,Waterproof
10030Tapes,Adhesive
10031Tapes,Adhesive,Hypoallergenic
10032Tapes,Adhesive,Waterproof
10033Adhesive Tape Removers
10034Adhesives
10035Adhesives,Aerosol
10036Adhesives,Liquid
10037Stools,Adjustable
10045Aerators,Ethylene Oxide
10046Aerosol Generators
10051Air Samplers
10053Airways
10056Airways,Esophageal Obturating
10057Airways,Nasopharyngeal
10058Airway Obstruction Removal Devices,
Emergency
10059Airways,Oropharyngeal
10077Alloys,Dental
10082Amalgamators
10085Ambulances
10086Ambulation Support Units
10088Amnioscopes
10089Amniotomes
10098Ampule Openers
10123Breathing Circuit Adapters
10124Anesthesia Kits
10125Anesthesia Kits,Brachial Plexus
10126Anesthesia Kits,Caudal
10127Anesthesia Kits,Epidural
10128Anesthesia Kits,Glossopharyngeal
10129Anesthesia Kits,Paracervical
10130Anesthesia Kits,Pudendal
10131Anesthesia Kits,Spinal
10134Anesthesia Units
10139Breathing Circuits,Anesthesia
10140Anesthesia Unit Absorbers,Carbon Dioxide 10142Anesthesia Unit Gas Scavengers
10144Anesthesia Unit Vaporizers
10145Anesthesia Unit Ventilators
10148Anesthesimeters
10149Stools,Anesthetist's
10152Angiotomes
10153Binders,Ankle
10155Anklets
10156Anoscopes
10164Apex Cardiographs
10168Applanometers
10171Jars,Applicator
10172Applicators
10173Applicators,Antiseptic
10174Applicators,Clip
10175Applicators,Eye
10176Applicators,Proctoscopic
10177Applicators,Tracheal
10182Baths,Arm
10183Covers,Arm Board UMDNS
CODE
UMDNS TERM English
10184Arm Boards
10185Arm Rests
10190Simulators,Arrhythmia
10197Arterioscopes
10198Arthroscopes
10199Articulators
10200Articulators,Cast
10201Articulators,Dental
10204Larynxes,Artificial
10208Aspirators
10211Canisters,Aspirator Collection
10212Aspirators,Dental
10214Aspirators,Infant
10215Aspirators,Low-Volume
10216Aspirators,Nasal
10217Aspirators,Surgical
10218Aspirators,Thoracic
10219Aspirators,Tracheal
10222Aspirators,Uterine
10223Aspirators,Wound
10224Ataxiagraphs
10225Atmocauteries
10226Atomizers
10228Audiometers
10229Audiometric Booths
10234Tourniquets,Pneumatic,Automatic Rotating 10239Autotransfusion Units
10243Baby Care Kits
10248Backrests
10261Balances
10263Balances,Electronic
10264Balances,Mechanical
10266Ballistocardiographs
10274Bandages
10276Bandages/Dressings,Adhesive
10278Adhesive Strips,Butterfly
10279Bandages,Elastic
10281Bandages,Gauze
10284Bandages,Pressure
10286Bandages,Scultetus
10288Bandages,Self-Adherent
10289Bandages,Traction
10291Bandages,Tubular
10297Metabolic Carts
10298Basin Stands
10302Bassinets
10304Bath Boots
10306Pillows,Bath
10316Bathtubs,Portable
10326Bed Boards
10328Bed Cradles
10334Cleaners,Bedpan
10335Covers,Bedpan
10336Racks,Bedpan
10338Warmers,Bedpan
10339Bedpans
10340Bedpans,Fracture
10341Bedrails
10342Beds
10345Beds,Circle Electric
10347Beds,Electric
10348Beds,Flotation Therapy
10351Beds,Fluoroscopic
10353Beds,Hydraulic
UMDNS
CODE
UMDNS TERM English
10356Beds,Labor
10357Beds,Mechanical
10360Beds,Orthopedic
10362Beds,Pediatric
10363Beds,Rocking
10368Stools,Bedside
10369Behavioral Therapy Units
10382Bibs
10383Ergometers,Bicycle
10385Exercisers,Bicycle
10386Bile Collection Bags
10396Biofeedback Systems
10397Biological Monitoring Systems 10401Biopsy Kits
10403Biopsy Kits,Ultrasonic Aspiration 10405Bite Blocks
10406Irrigation Kits,Bladder
10408Jars,Blade
10414Warmers,Blanket
10415Blankets
10416Blankets,Aluminized Rescue 10417Blankets,Infant
10421Blood Administration Sets
10425Blood Culture Kits
10426Blood Donor Sets
10429Blood-Flow Detectors,Ultrasonic 10430Flowmeters,Blood
10431Flowmeters,Blood,Electromagnetic 10432Flowmeters,Blood,Ultrasonic 10438Sampling Kits,Blood Gas
10440Lancets,Blood
10446Sampling Kits,Blood
10447Warmers,Blood/Solution
10455Cutters,Bone
10456Blades,Bone Cutting
10458Drivers,Bone Staple
10459Bone Wax
10479Brassieres
10480Brassieres,Maternity
10481Brassieres,Surgical
10483Binders,Breast
10484Breast Pads
10485Pumps,Breast
10486Breathing Bags
10491Bronchoscopes
10492Spirometers,Bronchial
10500Brushes
10502Brushes,Bur Cleaning
10503Brushes,Denture
10505Brushes,Eye
10506Brushes,Gingival
10507Brushes,Surgical Scrub
10509Brushes,Tracheal Tube
10510Bubble Detectors
10511Traps,Bubble
10516Burn Kits
10519Burs
10520Burs,Cranial
10521Burs,Dental
10522Burs,Podiatric
10526Cabinets
10529Cabinets,Anesthesia
10531Cabinets,Bedside
10532Cabinets,Dental UMDNS
CODE
UMDNS TERM English
10534Cabinets,Instrument
10535Cabinets,Medicine
10536Cabinets,Narcotic Control
10538Cabinets,Treatment,Ultraviolet 10540Cabinets,Warming
10541Cabinets,Pass Box,X-ray
10542Straps,Cable
10546Calipers
10547Calipers,Skinfold,Manual
10548Caloric Irrigation Units
10549Cameras
10551Cameras,Fundus
10552Cameras,Identification
10555Cameras,Newborn
10558Cameras,Oscilloscope
10559Cameras,Surgical
10560Canes
10561Cannulae
10564Cannulae,Arterial
10566Cannulae,Aspirating
10567Cannulae,Brain
10569Cannulae,Coronary Artery
10571Cannulae,Ear
10572Cannulae,Epidural
10573Cannulae,Eye
10574Cannulae,Eye,Cyclodialysis
10575Cannulae,Eye,Lacrimal
10576Cannulae,Femoral
10578Cannulae,Sinus
10580Cannulae,Uterine
10581Cannulae,Vena Caval
10582Cannulae,Venous
10588Carbon Dioxide Analyzers
10598Catheterization Kits,Cardiac
10608Cardiac Compression Boards
10613Cardiac Output Units
10614Cardiac Output Units,Direct Fick 10615Cardiac Output Units,Thermal Dilution 10617Cardiodynameters
10634Washers,Cart
10635Carts
10636Carts,Anesthetist's
10641Carts,Instrument
10642Carts,Isolation
10644Carts,Medication
10646Carts,Orthopedic Supply
10647Carts,Resuscitation
10650Carts,Traction
10655Cast Cutters
10656Cast Cutter Vacuums
10662Casting Units,Dental
10665Cast Material
10667Cast Boots
10668Shoes,Cast
10669Cast Stockinettes
10671Socks,Cast Toe
10672Cast Walking Heels
10673Cataract Extraction Units
10676Catheter Care Kits
10678Catheter Introducers
10685Catheters
10688Catheters,Angiography
10689Catheters,Arterial
10691Catheters,Arterial Micro-Flow
UMDNS
CODE
UMDNS TERM English
10694Catheters,Barium Enema
10695Catheters,Bartholin's Gland
10696Catheters,Biliary
10698Catheters,Cardiac
10700Catheters,Cardiac Balloon
10701Catheters,Cardiac Bypass
10702Catheters,Cardiac Percutaneous
10704Catheters,Cerebrospinal
10706Catheters,Coronary Perfusion
10709Catheters,DePezzer
10714Catheters,Embolectomy
10716Catheters,Esophageal Balloon
10717Catheters,Epidural
10718Catheters,Eustachian
10720Catheters,Urinary,Foley
10723Catheters,Hemostatic
10725Catheters,Intra-Aortic Balloon
10727Catheters,Intravenous,Peripheral
10729Catheters,Central Venous
10730Catheters,Irrigation
10731Catheters,Jejunostomy
10732Catheters,Mushroom
10734Catheters,Nelaton
10735Catheters,Nephrostomy
10736Catheters,Occlusion
10737Catheters,Olive Tip
10739Catheters,Perfusion
10741Catheters,Pericardium Drainage
10742Catheters,Peritoneal Dialysis
10746Catheters,Rectal
10747Catheters,Septostomy
10748Catheters,Single-Needle Hemodialysis 10749Catheters,Suction
10751Catheters,Suprapubic
10754Catheters,Cardiac Balloon,Thermal Dilution 10756Catheters,Thrombectomy
10759Catheters,Umbilical
10760Catheters,Umbrella
10761Catheters,Ureteral
10762Catheters,Urethral
10763Catheters,Urethral,Diagnostic
10764Catheters,Urinary
10765Catheters,Urinary,Condom
10767Catheters,Urinary,Irrigation
10769Catheters,Intracranial,Ventricular
10776Manometer Sets,Venous,Central/Peripheral 10778Centrifuges
10779Centrifuges,Microhematocrit
10780Centrifuges,Tabletop
10787Chairs
10788Chairs,Bath
10789Chairs,Blood Drawing
10790Chairs,Cardiac
10792Chairs,Dental
10794Chairs,Examination/Treatment,
Ear/Nose/Throat
10795Chairs,Flotation Therapy
10796Chairs,Geriatric
10797Chairs,Pediatric
10799Chairs,Podiatric
10801Chairs,Rehabilitation
10802Chairs,Shower
10810Recorders,Chart
10816Binders,Chest UMDNS
CODE
UMDNS TERM English
10817Drainage Systems,Pleural
10822Radiographic Units,Chest
10824Chisels
10825Chisels,Bone
10827Chisels,Mastoid
10828Chisels,Nasal
10829Chisels,Orthopedic
10831Choledochoscopes
10832Chromoradiometers
10833Chronaximeters
10838Circuit Breaker Testers
10839Circulatory Assist Units
10840Circulatory Assist Units,Cardiac
10846Circulatory Assist Units,Intra-Aortic Balloon 10847Circulatory Assist Units,Ventricular
10849Circulatory Assist Units,Venous Return 10858Circumcision Trays
10859Circumcision Trays,Disposable
10860Circumcision Trays,Reusable
10861Clamps
10864Clamps,Aorta
10865Clamps,Artery
10866Clamps,Bone
10867Clamps,Bronchus
10868Clamps,Bulldog
10869Clamps,Circumcision
10870Clamps,Hemorrhoidal
10871Clamps,Intestinal
10872Clamps,Patent Ductus
10873Clamps,Peripheral Vascular
10875Clamps,Tubing
10876Clamps,Umbilical
10894Clip Appliers
10895Clip Removers
10898Clips
10901Clips,Bandage
10902Clips,Drape
10904Clips,Instrument
10905Clips,Aneurysm
10906Clips,Iris
10907Clips,Nose
10908Clips,Penis
10909Clips,Scalp
10910Clips,Skin
10911Clips,Suture
10914Clips,Towel
10915Clips,Vena Caval
10916Clips,Wound
10918Clocks,Elapsed-Time
10932Cold Packs
10937Collars
10938Collars,Cervical
10941Collectors
10943Collectors,Sputum
10944Collectors,Urine
10950Colonoscopes
10951Coloscopes
10960Colposcopes
10961Commode Seats
10962Commodes
10964Compimeters
10965Compresses
10966Compresses,Gauze
10967Compresses,Moist Heat
UMDNS
CODE
UMDNS TERM English
10969Compression Units,Intermittent
10971Compressors
10972Compressors,Medical-Air
10977Computers
10980Computers,Cardiac Catheterization Laboratory 10981Computers,ECG Interpretation
10984Computers,Pulmonary Function Laboratory 10985Condoms
10986Aprons,Conductive
10990Testers,Conductivity
10992Testers,Conductivity,Floor and Equipment 10993Testers,Conductivity,Gown
10994Testers,Conductivity,Shoe
10995Cleaners,Contact Lens
10996Contact Lenses
11001Continuous Positive Airway Pressure Units 11003Contourographs
11009Controllers
11010Infusion Controllers
11017Cornish Hemostatic Wool
11023Correlators,Retinal
11024Corsets
11028Cotton Balls
11049Crib Tops
11052Cricothyreotomes
11058Dental Crowns,Preformed
11059Crushers
11060Crushers,Fascia
11062Crutch Pads
11063Crutches
11066Cryometers
11067Cryosurgical Units,General-Purpose
11068Cryosurgical Units,Ophthalmic
11071Cuff Inflators
11072Cuffs
11073Cuffs,Blood Pressure
11079Culdoscopes
11084Curets
11089Current Limiters,Patient Leads
11090Curtains,Cubicle,Reusable
11093Cushions
11095Cushions,Foot
11096Cushions,Ring
11097Cushions,Ring,Foam Rubber
11098Cushions,Ring,Inflatable
11099Cushions,Stool
11100Cushions,Wheelchair
11101Cuspidors
11111Cystometers
11112Cystoscopes
11113Cystitomes
11114Cystourethroscopes
11122Decapitation Instruments
11126Decompression Units,Abdominal
11127Defibrillator Analyzers
11129Defibrillator/Monitors
11130Defibrillator Paddle Pads
11132Defibrillators
11133Defibrillators,Internal
11134Defibrillators,Battery-Powered
11137Defibrillators,Line-Powered
11141Delivery Kits
11145Demineralizers
11150Cement,Dental UMDNS
CODE
UMDNS TERM English
11155Rubber Dams,Dental
11156Dental Engines
11158Dental Floss
11159Dental Foil,Gold
11160Dental Hand Instruments
11161Handpieces,Dental
11164Stools,Dental
11165Dental Delivery Units
11167Dentaphones
11168Dentifrice
11169Cups,Denture
11170Denture Cushions
11171Denture Repair Kits
11172Dentures,Preformed
11177Dermabrasion Units
11179Dermatomes
11182Dermohygrometers
11183Dermotherms
11184Desensitizers
11202Device Status Tags
11206Dialysate Conductivity Meters
11211Dialysate Delivery Systems,Multipatient 11213Dialysate Delivery Systems,Single-Patient 11218Hemodialysis Units
11219Hemodialysis Unit Air Bubble-Foam Detectors 11220Hemodialysis Unit Blood Pumps
11222Hemodialysis Unit Conductivity Monitors 11224Hemodialysis Unit Single-Needle Controllers 11225Hemodialysis Tubing Sets
11226Peritoneal Dialysis Units
11227Peritoneal Dialysis Unit Tubing Sets
11228Dialysis Unit Test Equipment
11230Dialyzers
11232Dialyzers,Hemodialysis
11233Dialyzers,Hemodialysis,Coil
11234Dialyzers,Hemodialysis,Hollow-Fiber
11235Dialyzers,Hemodialysis,Parallel-Plate 11237Diamond Rotary Instruments
11238Diapers
11239Diapers,Adult
11240Diapers,Pediatric
11244Diathermy Units
11245Diathermy Units,Microwave
11246Diathermy Units,Shortwave
11248Ultrasound Units,Physical Therapy
11253Dilatometers
11254Dilators
11255Dilators,Cardiac
11256Dilators,Common Duct
11257Dilators,Esophageal
11259Dilators,Lacrimal
11260Dilators,Nasal
11261Dilators,Pulmonary
11262Dilators,Rectal
11263Dilators,Tracheal
11264Dilators,Tubal
11265Dilators,Urethral
11266Dilators,Uterine
11267Dilators,Vaginal
11268Dilators,Vascular
11269Diopsimeters
11274Directoscopes
11278Disinfectors
11279Disinfecting Units,Liquid,Flexible Endoscope
UMDNS
CODE
UMDNS TERM English
11280Disinfectors,Pasteurization
11282Disks,Dental
11283Dispensers
11284Dispensers,Brush
11285Dispensers,Fluid
11287Unit-Dose Dispensers,Pill,Narcotic Control 11289Dissecting Kits
11290Dissectors
11291Distractors
11293Dolorimeters
11295Dosimeters,Radiation
11297Douche Kits
11298Douche Nozzles
11301Drainage Bags
11303Bottles,Drainage
11304Drains
11305Drains,Wound
11307Drains,T
11308Drains,Thoracic
11310Drains,Vent
11313Jars,Dressing
11314Dressing Kits
11315Dressings
11321Dressings,Aerosol
11322Dressings,Burn
11323Dressings,Foam
11324Dressings,Germicidal
11325Dressings,Nonadherent
11326Dressing Pads
11327Dressings,Roller Gauze
11328Dressings,Universal
11329Drills
11330Drills,Biopsy
11331Drills,Bone
11332Drills,Cannulated
11333Drills,Cervical
11334Perforators,Cranial,Automatic
11337Drills,Fingernail
11338Drills,Intramedullary
11339Drills,Middle Ear Surgery
11341Burs,Oral Surgery
11342Drills,Perforator
11345Driver/Extractors
11346Driver/Extractors,Bone Nail-Pin
11347Driver/Extractors,Bone Plate
11359Duodenoscopes
11365Dynamometers,Other
11367Dynamometers,Squeeze
11369Bougies,Ear
11370Droppers,Ear
11371Irrigation Kits,Ear
11374Ear Piercing Instruments
11375Ear Plugs
11376Syringes,Ear
11379ECG Monitor Analyzers
11381Simulators,ECG
11385Recorders,Echocardiographic
11387Echoencephalographs
11389Scanners,Ultrasonic,Ophthalmic
11391Eikonometers
11393Ejectors,Saliva
11394Elastomers,Silicone Rubber
11399Electrical Safety Analyzers
11401Electrobasographs UMDNS
CODE
UMDNS TERM English
11402Electrocardiocontourographs
11407Electrocardiographs
11410Electrocardiograph Cable Testers
11411Electrocardiographs,Multichannel
11413Electrocardiographs,Single-Channel
11418Electrocautery Units
11421Electrocautery Units,Battery-Powered
11422Electrocautery Units,Line-Powered
11425Gel,Electrode
11426Testers,Electrode
11429Electrode Straps
11431Electrodes,Blood Gas
11432Electrodes,Blood Gas,Carbon Dioxide 11433Electrodes,Blood Gas,Oxygen
11434Electrodes,Catheter Tip
11436Electrodes,Cystoscopic
11439Electrodes,Electrocardiographic
11440Electrodes,Electroencephalographic
11441Electrodes,Electromyographic
11442Electrodes,Electronystagmographic
11443Electrodes,Electrooculogram
11444Electrodes,Electroshock
11446Electrodes,Esophageal
11447Electrodes,Fetal Scalp
11452Electrodes,Nasopharyngeal
11453Electrodes,Neurological
11454Electrodes,Neuromuscular Stimulator
11458Leads,Pacemaker,Implantable Myocardial 11460Electrodes,Electroretinographic
11461Electrodes,Sweat Test
11467Electroencephalographs
11471Electrogoniometers
11473Electromanometers
11474Electromyographs
11479Electronystagmographs
11480Electrooculographs
11482Electroretinographs
11483Electrorheographs
11484Electroconvulsive Therapy Units
11485Electrosleep Units
11487Electrostatic Voltage Detectors
11489Electrosurgical Unit Analyzers
11490Electrosurgical Units
11493Electrosurgical Unit Adapters,Cable
11494Electrosurgical Unit Adapters,Hand Control 11496Cables/Leads,Electrosurgical Unit
11497Electrode Holders,Electrosurgical
11499Electrodes,Electrosurgical,Active,Hand-
Controlled
11500Electrodes,Electrosurgical,Return
11502Forceps,Electrosurgical
11503Electrotherapeutic Units
11504Elevators
11506Elevators,ENT
11507Elevators,Neurosurgical
11508Elevators,Orthopedic
11515Emergency Drug Kits
11522Basins,Emesis
11526Encephaloscopes
11529Endoradiographs
11530Endoradiosondes
11531Sampling Kits,Endometrial
11576Endoscopic Power Supplies
11577Endoscopic Power Supplies,Battery-Operated
UMDNS
CODE
UMDNS TERM English
11578Endoscopic Power Supplies,Line-Operated 11581Enema Bags
11582Enema Kits
11583Enema Tips
11585Ear/Nose/Throat Treatment Units
11587Enucleators
11588Alarms,Enuresis
11589Epilators
11592Ergometers
11597Bougies,Esophageal
11599Esophageal Coolers
11600Esophageal Motility Analyzers
11601Stethoscopes,Esophageal
11603Esophagoscopes
11604Esthesiometers
11606Droppers,Ether
11608Ethylene Oxide Analyzers
11614Evoked-Potential Units
11617Excavators,Endaural
11618Exchange Transfusion Kits
11620Exercise Stairs
11621Stools,Exercise
11623Exercisers
11625Exercisers,Arm
11627Exercisers,Chest
11628Exercisers,Finger
11629Exercisers,Hand
11630Exercisers,Leg and Ankle
11631Exercisers,Continuous Passive Motion 11633Quadriceps Boards
11634Exercisers,Respiratory
11636Exercisers,Shoulder
11638Exercisers,Trapeze
11652Charts,Eye
11653Cups,Eye
11654Droppers,Eye
11655Irrigation Kits,Eye
11657Masks,Eye
11659Masks,Eye,Phototherapy
11661Eye Pads
11663Shields,Eye
11667Eyeglasses
11675Enteral Feeding Bags
11677Enteral Feeding Kits
11684Fenestrometers
11692Fetal Heart Detectors
11695Fetal Heart Detectors,Phono
11696Fetal Heart Detectors,Ultrasonic
11700Fibrillators
11701Files
11702Files,Bone
11703Files,Callous
11704Filiforms
11710Filters
11711Filters,Air
11712Filters,Bacteria
11713Filters,Blood
11716Filters,Intravenous Tubing
11717Filters,Kidney Stone
11718Filters,Vena Cava
11719Finger Cots
11720Finger Protectors
11723First Aid Kits
11726Fittings/Adapters UMDNS
CODE
UMDNS TERM English
11727Fittings/Adapters,Pneumatic,DISS
11729Fittings/Adapters,Luer
11731Fittings/Adapters,Pneumatic,Quick-Connect 11736Flicker-Fusion Units
11740Floor Mats,Antibacterial
11744Flow Timers
11745Flow Totalizers
11746Flowmeters
11748Flowmeters,Gas
11751Dressings,Fluff
11757Radiographic/Fluoroscopic Units,General-Purpose
11758Radiographic/Fluoroscopic Units,Mobile 11761Fluxmeters
11769Foot Boards
11771Footstools
11772Footstools,Conductive
11773Footstools,Nonconductive
11774Forceps
11775Forceps,Biopsy
11777Forceps,Dressing
11779Forceps,Laparoscopic
11780Forceps,Epilation
11781Forceps,Fixation
11782Forceps,Gallbladder
11784Forceps,Hemostatic
11785Forceps,Intestinal
11787Forceps,Lung
11788Forceps,Obstetrical
11790Forceps,Specimen
11791Forceps,Sponge
11792Forceps,Sterilizer Transfer
11793Forceps,Stone Manipulation
11794Forceps,Suction
11797Forceps,Tissue
11798Forceps,Utility
11799Jars,Forceps
11802Forensic Evidence Kits
11803Forensic Evidence Kits,Sexual Assault 11814Fume Evacuators
11822Gags
11825Beta/Gamma Detectors
11835Carriers,Medical Device
11838Gas Cylinder Stands/Holders
11848Gas Sampling Units
11850Gasometers
11853Gastroduodenoscopes
11854Gastrographs
11856Gastroscopes
11857Gastroscopes,Flexible
11858Gastroscopes,Rigid
11859Gauze
11868Cups,Geriatric Feeding
11878Glove Processing Units
11879Gloves
11880Gloves,Autopsy
11882Gloves,Examination/Treatment
11883Gloves,Surgical
11884Gloves,Surgical,Hypoallergenic
11885Gloves,Utility
11893Goniometers
11894Gonioscopes
11895Gouges
11897Gowns
UMDNS
CODE
UMDNS TERM English
11898Gowns,Operating Room
11901Gowns,Operating Room,Disposable 11902Gowns,Operating Room,Reusable 11903Gowns,Patient
11904Gowns,Patient,Disposable
11905Gowns,Patient,Reusable
11908Grafts
11910Grafts,Bone
11912Grafts,Skin
11913Prostheses,Blood Vessel,Biological 11919Ground Fault Circuit Interrupter Testers 11920Ground Fault Circuit Interrupters
11923Grounding System Testers
11925Guide Wires
11927Guides
11930Guides,Drill
11931Guides,Gigli Saw
11933Guillotines
11934Guillotines,Adenoid
11935Guillotines,Tonsil
11937Gustometers
11939Clippers,Hair
11941Halogenated Anesthetics Analyzers 11947Hammers
11949Hammers,Neurological
11950Hammers,Percussion
11958Head Halters
11960Head Mirrors
11961Shields,Face
11962Head Tanks
11963Headlights
11964Headrests
11967Hearing Aids
11969Heart-Lung Bypass Units
11973Heat Exchangers,Heart-Lung Bypass 11974Oxygenators,Extracorporeal Bubble 11975Pulsatile Pressure Generators,Heart-Lung Bypass Unit
11977Simulators,Heart Sound
11978Heat Exchangers
11985Heating Pads
11988Pads,Circulating-Fluid,Localized
Heating/Cooling
11989Heating Pads,Electric
11991Heel Stirrups
11995Surgical Helmet Systems
11996Hemacytometers
12001Hemoperfusion Systems
12009His Bundle Detectors
12021Hoods
12022Hoods,Chemical Fume
12025Hoods,Isolation,Laminar Air Flow
12027Hoods,Oxygen
12028Hooks
12029Hooks,Cordotomy
12030Hooks,Ether
12031Hooks,Incus
12032Hooks,Intrauterine Device Removal 12033Hooks,Rhinoplastic
12034Hooks,Scleral Fixation
12035Hooks,Skin
12036Hooks,Strabismus
12037Hooks,Sympathectomy
12038Hooks,Tracheal UMDNS
CODE
UMDNS TERM English
12040Hot Packs
12042Bottles,Hot/Cold Water
12047Humidifiers
12050Humidifiers,Heated
12051Humidifiers,Nonheated
12059Hygrometers
12061Chambers,Hyperbaric
12066Hyperthermia Units,Radio-Frequency 12067Hypo/Hyperthermia Blankets
12068Hypo/Hyperthermia Units
12074Hypo/Hyperthermia Units,Central
12075Hypo/Hyperthermia Units,Mobile,General-Purpose
12076Chambers,Hypobaric
12078Hypothermia Units
12081Hysteroscopes
12082Ice Bags
12085Collars,Ice
12088Identification Bracelets
12093Immobilizers
12094Immobilizers,Ankle
12095Immobilizers,Arm
12096Immobilizers,Elbow
12097Immobilizers,Infant
12099Immobilizers,Knee
12101Immobilizers,Shoulder
12102Immobilizers,Wrist
12103Impedance Cardiographs
12108Incision and Drainage Kits
12109Incontinence Clamps
12110Linen Protection Pads
12111Incontinence Pants
12112Incubators
12113Incubators,Infant
12114Incubators,Infant,Transport
12128Inhalers,Aerosol
12129Injectors
12132Injectors,Medication/Vaccine,Syringe 12134Injectors,Thermal Dilution
12135Insect Sting Emergency Kits
12142Racks,Instrument
12143Trays,Instrument
12144Insufflators
12152Intracervical Devices
12155Intrauterine Balloons
12156Intrauterine Devices
12157Intravenous Administration Sets
12159Intravenous Administration Sets,Buret 12161Catheterization Kits,Intravenous
12162Intravenous Catheter-Needle Immobilizers 12168Counters,Intravenous Drop
12170Intravenous Extension Tubing Kits
12171Flowmeters,Intravenous
12172Intravenous Fluid Containers
12173Intravenous Hangers
12177Intravenous Poles
12184Ionized Air Generators
12185Iontophoresis Units
12199Testers,Isolated Power System
12200Chambers,Isolation
12222Keratomes
12223Kick Bucket Liners
12229Kinesthesiometers
12234Blades,Knife
UMDNS
CODE
UMDNS TERM English
12235Knife Handles
12236Knife Holders
12237Knife Needles
12239Knives
12240Knives,Amputating
12241Knives,Cataract
12242Knives,Commissurotomy
12243Knives,Dermatome
12244Knives,Dural Hook
12245Knives,Ear
12247Knives,Keratome
12248Knives,Meniscus
12249Knives,Microtome
12250Knives,Paraffin
12251Knives,Plaster
12252Knives,Scalpel
12253Knives,Skin Grafting
12254Knives,Sternum
12255Knives,Tonsil
12268Laminar Air Flow Units
12270Laminaria Tents
12276Lights,Examination
12278Lights,Infrared
12279Lights,Perineal Heat
12281Slit Lamps
12282Lights,Surgical
12283Lights,Ultraviolet
12284Lights,Ultraviolet,Germicidal
12291Laparoscopes
12292Tubes,Laryngectomy
12293Laryngoscopes
12294Laryngostroboscopes
12296Lasers
12299Lasers,Therapeutic
12300Lavage Units
12301Lavage Units,Colonic
12302Lavage Units,Corneal
12304Lavage Units,Dental/Oral
12305Lavage Units,Otorhinolaryngological
12306Lavage Units,Surgical
12311Leakage Current Meters
12313Baths,Leg
12315Leg Rests
12318Lens Expressors
12319Lens Loops
12321Lens Spoons
12322Lenses
12324Lenses,Intraocular
12326Lensometers
12327Lesion Generators
12329Lifts
12330Lifts,Patient Transfer
12331Lifts,Wheelchair,Vertical
12332Ligators
12335Ligators,Hemorrhoid
12336Ligature Carriers
12340Light Sources
12343Light Sources,Fiberoptic,Flexible Endoscopic 12345Light Sources,Fiberoptic
12346Light Sources,Flash
12347Lights
12351Lights,Dental
12352Lights,Dental,Intraoral
12361Line Isolation Monitors UMDNS
CODE
UMDNS TERM English
12364Linear Accelerators
12368Drapes,Surgical
12369Laundry Bags,Operating Room
12370Sheets,Operating Room
12374Lingual Palatal Bars
12377Lithometers
12379Lithotrites
12385Recorders,Long-Term
12386Recorders,Long-Term,Blood Pressure,
Portable
12387Recorders,Long-Term,ECG
12388Recorders,Long-Term,ECG,Portable 12389Recorders,Long-Term,EEG
12390Recorders,Long-Term,Oxygen
12391Recorders,Long-Term,Trend
12393Loops
12394Loops,Endarterectomy
12396Loops,Tracheal
12397Loops,Vascular
12398Drivers,Nail
12401Lubricating Jellies
12404Lumbar Puncture Kits
12405Belts,Lumbosacral
12408Simulators,Lung
12409Lymphangiographic Kits
12415Magnetic Units,Therapeutic
12416Magnetocardiographs
12417Magnetometers
12421Mallets
12423Mallets,Bone
12424Mallets,Dental
12425Radiographic Units,Mammographic
12429Mandrels
12432Manometers,Aneroid
12440Markers
12441Markers,Implantable Radiographic
12442Markers,Ocular
12443Markers,Skin
12447Masks
12448Masks,Air-Oxygen
12449Masks,Air-Oxygen,Aerosol Administration 12450Masks,Air-Oxygen,Nonrebreathing
12451Masks,Air-Oxygen,Partial Rebreathing 12452Masks,Air-Oxygen,Venturi
12453Masks,Anesthesia
12458Masks,Surgical
12459Masks,Tracheostomy
12460Masks,Tracheostomy,Aerosol Administration 12461Mass Screening Systems
12463Maternity Kits
12467Covers,Mattress
12468Covers,Mattress,Conductive
12469Covers,Mattress,Waterproof
12473Mattresses
12475Mattresses,Bed
12477Mattresses,Metabolic
12478Mattresses,Operating Table
12479Mattresses,Vacuum
12480Mattresses,Water
12499Mediastinoscopes
12500Medical Bags
12501Medical Chart Holders
12502Medical Chart Racks
12504Injectors,Medication/Vaccine
UMDNS
CODE
UMDNS TERM English
12505Cups,Medicine
12506Droppers,Medicine
12507Trays,Medicine
12510Mesh,Polymeric
12516Metal Detectors,Magnetic
12518Metal Detectors,Photographic
12519Metal Detectors,Ultrasonic
12521Extractors,Metal,Magnetic
12524Metreurynters
12529Microelectrode Amplifiers
12530Microelectrode Pullers
12531Microelectrodes
12533Microgasometers
12534Micromanipulators
12535Covers,Microscope
12536Microscopes
12537Microscopes,Corneal
12538Microscopes,Ear
12539Microscopes,Operating
12540Microwave Leakage Detectors
12542Midstream Collection Kits
12547Mirrors
12549Mirrors,Laryngeal
12550Mirrors,Middle Ear
12551Mirrors,Obstetrical
12552Mirrors,Posture
12553Mirrors,Speech
12554Tents,Mist
12557Tents,Mist,Face
12559Mitts,Patient
12560Mixing Slabs
12565Moist Heat Therapy Pack Conditioners 12566Moist Heat Therapy Packs
12570Moleskins
12575Apnea Monitors
12585Alarms,Bed Occupancy
12586Blood Gas Monitors
12588Blood Gas Monitors,Carbon Dioxide
12590Blood Gas Monitors,Oxygen
12592Oxygen Monitors,Transcutaneous
12597Cerebral Function Monitors
12599ECG Monitors
12601ECG Monitors,Arrhythmia
12602EEG Monitors
12606Environmental Monitors,Atmospheric Gas 12609Eye Movement Monitors
12610Fetal Monitors
12614Heart Rate Monitors
12618Heart Rate Monitors,R-Wave
12621Impedance Pneumograph Monitors
12634pH Monitors
12636Physiologic Monitoring Systems
12647Physiologic Monitoring Systems,Acute Care 12648Physiologic Monitoring Systems,Cardiac Catheterization
12649Physiologic Monitoring Systems,Stress
Exercise
12657Pulse Monitors
12660Radiation Monitors
12662Respiration Monitors
12672Temperature Monitors
12678Ventilation Monitors
12684Traps,Mucus
12689Myelogram Kits UMDNS
CODE
UMDNS TERM English
12690Myeloscopes
12692Myographs
12695Clippers,Nail
12696Extractors,Nail
12699Balloons,Nasal
12700Cannulae,Nasal Oxygen
12701Cannulae,Nasal Oxygen,Continuous Positive Airway Pressure
12702Catheters,Nasal Oxygen
12704Nasal Septum Buttons
12705Nasogastric Headbands
12706Nasographs
12709Nasopharyngoscopes
12710Nasoscopes
12711Nebulizer Testers
12712Nebulizers
12716Nebulizers,Heated
12719Nebulizers,Ultrasonic
12723Cleaners,Needle
12724Counters,Needle
12726Needle Holders
12727Needle Introducers
12729Needles
12730Needles,Acupuncture
12732Needles,Airway
12733Needles,Anesthesia
12734Needles,Biopsy
12736Needles,Blood-Collecting
12737Needles,Blunt
12738Needles,Cardiac
12739Needles,Cholangiographic
12740Needles,Dental
12741Needles,Dialysis
12744Needles,Eye
12745Needles,Hypodermic
12747Needles,Intra-Arterial
12748Needles,Intravenous
12750Needles,Pneumoperitoneal
12751Needles,Radiographic
12752Needles,Scalp-Vein Type
12753Needles,Spinal
12754Needles,Suture
12766Nippers,Malleus
12768Nitrous Oxide Analyzers
12774Droppers,Nose
12779Bottles,Infant Nursing
12784Observerscopes
12789Obturators
12791Oculoplethysmographs
12796Olfactometers
12799Cardiointegraphs
12800Oncometers
12804Ophthalmodiaphanoscopes
12805Ophthalmodiastimeters
12809Ophthalmographs
12810Ophthalmoleukoscopes
12811Ophthalmometers
12813Ophthalmometroscopes
12815Ophthalmoscopes
12817Ophthalmoscopes,Direct
12818Ophthalmoscopes,Indirect
12820Ophthalmotropometers
12821Optometers
12822Optomyometers
UMDNS
CODE
UMDNS TERM English
12823Oral Administration Sets
12825Orange Sticks
12826Organ Preservation Systems
12830Cement,Orthopedic
12833Orthopedic Internal Fixation Systems,Fracture 12837Orthoses
12839Oscilloscopes
12841Oscillotonometers
12842Osmometers
12844Osteotomes
12845Osteotomes,Orthopedic
12846Osteotomes,Plastic Surgery
12847Ostomy Appliances
12849Otoscopes
12853Oximeters
12855Oxygen Administration Kits
12858Oxygen Analyzers
12861Oxygen Analyzers,Continuous Controlling 12863Oxygen Monitors
12868Oxygen Canisters
12873Oxygen Concentrators
12875Tubing,Oxygen Connecting
12876Oxygen-Air Proportioners
12879Alarms,Oxygen Depletion
12883Oxygen Generators
12893Tents,Oxygen
12899Ozone Generators
12900Leads,Pacemaker,Implantable Endocardial 12911Pacemakers,Cardiac
12912Pacemakers,Cardiac,External Invasive 12913Pacemakers,Cardiac,Implantable
12928Pressure Pads,Alternating
12934Medicated Pads
12935Percussion Pads
12936Pressure Pads
12940Pressure Pads,Air
12941Pressure Pads,Animal Skin
12942Pressure Pads,Foam
12943Pressure Pads,Foam Convoluted
12944Pressure Pads,Gel
12945Pressure Pads,Mud
12946Pressure Pads,Water Cushion
12950Pain Gauges,Cutaneous
12955Papanicolaou Smear Kits
12956Baths,Paraffin,Physical Therapy
12957Parallel Bars
12962Parturiometers
12963Cabinets,Pass-Through
12971Patient Utensil Kits
12980Pelvimeters
12981Pelviscopes
12984Penetrometers
12986Percussors
12989Perforators
12990Perforators,Amniotic Membrane
12991Perforators,Ear Lobe
12993Perimeters
12996Irrigation Kits,Perineal
12998Peripheral Vision Analyzers
13003Peritoneoscopes
13004Pessaries
13005Pessaries,Diaphragm
13006Phaneroscopes
13008Phantoms UMDNS
CODE
UMDNS TERM English
13009Phantoms,Radiographic
13010Phantoms,Ultrasound
13011Pharyngoscopes
13012Phlebographs
13017Phonocardiographs
13018Phonocatheters
13020Phonostethographs
13022Photocatheters
13026Photofluorometers
13027Photofluoroscopes
13031Light Meters,Photomicrographic 13037Phototherapy Units
13039Picks,Middle Ear
13041Cutters,Pin and Wire
13043Pinwheels
13049Plates
13050Plates,Bone
13052Plates,Cranioplasty
13055Pledgets
13056Plethysmographs
13059Plethysmographs,Body
13069Pneumatic Counterpressure Suits 13074Pneumatic Testers
13078Pneumographs
13080Pneumotachographs
13081Pneumothorax Units
13085Polygraphs
13088Baths,Portable
13090Charts,Posture
13097Prep Kits
13100Pressure Infusors
13102Pressure Measuring Units
13106Sphygmomanometers
13107Manometer Sets,Cerebrospinal Fluid 13108Pressure Measuring Units,Esophageal 13109Pressure Measuring Units,Inspiratory 13110Pressure Measuring Units,Intracranial 13114Calibrators,Pressure Transducer 13116Covers,Thermometer,Electronic Probe 13117Probes
13118Probes,Common Duct
13119Probes,Eye
13120Probes,Eye,Lacrimal
13121Probes,Fistula
13124Probes,Sinus
13125Probes,Thermometer
13126Proctoscopes
13127Proctosigmoidoscopes
13129Prophylaxis Kits,Dental
13131Prostheses
13134Prostheses,Arm
13135Prostheses,Bile Duct
13136Prostheses,Bladder Support
13138Prostheses,Cardiac Valve
13139Prostheses,Cerclage,Cervix
13140Prostheses,Chin
13143Prostheses,Ear
13145Prostheses,Esophageal
13146Spheres,Eye
13148Prostheses,Fallopian Tube
13150Prostheses,Foot
13151Prostheses,Hand
13152Prostheses,Heart
13158Prostheses,Joint
UMDNS
CODE
UMDNS TERM English
13159Prostheses,Larynx
13160Prostheses,Leg
13161Prostheses,Mammary
13162Prostheses,Maxillofacial
13164Prostheses,Muscle
13165Patches,Myocardial
13167Prostheses,Penile
13168Prostheses,Joint,Wrist
13171Prostheses,Tendon
13172Prostheses,Testicle
13174Prostheses,Tracheobronchial
13175Prostheses,Urethral
13176Prostheses,Urethral Sphincter
13177Prostheses,Blood Vessel,Artificial
13180Prosthesis Implantation Instruments,
Orthopedic
13182Pulmonary Function Analyzers,Adult 13187Testers,Pulp
13188Pulsatile Pressure Generators
13192Pumps
13201Pumps,Dye Dilution
13203Pumps,Extracorporeal Perfusion
13209Pumps,Enteral Feeding
13215Infusion Pumps,General-Purpose
13217Infusion Pumps,Syringe
13220Infusion-Withdrawal Pumps
13224Pumps,Obstetrical Decompression
13228Punches
13229Punches,Aortic
13230Punches,Biopsy
13231Punches,Bone
13232Punches,Corneoscleral
13233Punches,Dermal
13234Punches,Hair Transplant
13235Pupillographs
13236Pupillometers
13237Pyeloscopes
13239Pyrometers
13241Pyroscopes
13248Warmers,Radiant
13249Warmers,Radiant,Adult
13250Warmers,Radiant,Infant
13251Warmers,Radiant,Infant,Transport 13252Radiation Counters
13259X-ray Film Duplicators
13260Positioning Aids,
Radiographic/Radiotherapeutic
13267Radiographic Units
13269Radiographic Units,Dental
13271Radiographic Units,General-Purpose 13272Radiographic Units,Mobile
13274Recorders,Video Tape
13275Calibrators,Radioisotope
13276Radioisotope Transfer Units
13278Radiometers,Phototherapy
13279Radiotherapy Units
13280Simulators,Radiotherapy
13281Computers,Radiotherapy Planning System 13287Raspatories
13288Rasps
13289Rasps,Middle Ear
13290Rasps,Nasal
13291Rasps,Plastic Surgery
13297Reamers,Orthopedic UMDNS
CODE
UMDNS TERM English
13299Testers,Power,Receptacle,Electrical 13300Testers,Power,Receptacle,Mechanical 13313Refractors,Ophthalmologic
13314Alarms,Refrigerator
13315Refrigerators
13316Refrigerators,Morgue
13317Regional Perfusion Units
13318Heat Exchangers,Regional Perfusion 13319Oxygenators,Regional Perfusion 13320Regulators
13323Regulators,High-Pressure Gas
13325Regulators,Suction
13329Regulators,Suction,Low-Volume 13332Regulators,Suction,Thoracic
13333Regulators,Suction,Tracheal
13335Resectoscopes
13338Reservoirs,Cardiotomy
13340Testers,Resistance,Line Cord
13341Simulators,Respiration
13346Restraints
13347Restraints,Ankle
13348Restraints,Arm
13349Restraints,Body
13351Restraints,Crib
13355Restraints,Vest
13356Restraints,Wheelchair Occupant
13357Restraints,Wrist
13360Resuscitators
13361Resuscitators,Cardiac
13363Resuscitators,Cardiopulmonary
13364Resuscitators,Pulmonary
13366Resuscitators,Pulmonary,Gas-Powered 13367Resuscitators,Pulmonary,Manual 13368Retainers
13369Retainers,Bandage
13370Retainers,Orthodontic
13371Retainers,Visceral
13372Retinoscopes
13373Retractors
13375Retractors,Abdominal
13376Retractors,Bladder
13377Retractors,Brain
13378Retractors,Brain Decompression 13379Retractors,Cardiac
13380Retractors,Dental
13381Retractors,Eye
13383Retractors,Hand Operating
13384Retractors,Laminectomy
13385Retractors,Orbital
13386Retractors,Orthopedic
13387Retractors,Plastic Surgery
13388Retractors,Rectal
13389Retractors,Rib
13390Retractors,Self-Retaining Operating 13391Retractors,Thoracic
13392Retractors,Vaginal
13393Retractors,Vessel
13395Rhinoanemometers
13396Rhinoscopes
13399Cutters,Ring
13403Dental Casting Rings
13414Cotton Rolls
13416Rongeurs
13418Rongeurs,Neurosurgical
UMDNS
CODE
UMDNS TERM English
13419Rongeurs,Rib
13425Routers,Bone Cutting
13426Rowing Units
13427Rubber Dams
13432Safes,Isotope
13439Sand Bags
13441Sanitary Belts
13443Sanitary Pads
13444Sanitizers
13447Blades,Saw
13448Saws
13449Saws,Bone
13450Saws,Bone,Electrical
13451Saws,Bone,Manual
13452Saws,Bone,Pneumatic
13454Scalers
13455Scales
13457Scales,Autopsy
13458Scales,Bed
13459Scales,Blood
13460Scales,Chair
13461Scales,Floor
13462Scales,Infant
13463Scales,Sponge
13468Scanners
13469Scanners,Computed Tomography 13472Scarifiers
13480Scissors
13481Scissors,Bandage
13482Scissors,Cardiovascular
13484Scissors,Endoscopic
13485Scissors,Eye
13486Scissors,Eye,Corneal
13487Scissors,Eye,Enucleation
13488Scissors,Eye,Iris
13489Scissors,Eye,Suture
13490Scissors,Eye,Tenotomy
13492Scissors,Dissecting
13493Scissors,Gynecological
13495Scissors,Nasal
13496Scissors,Neurosurgical
13498Scissors,Orthopedic
13499Scissors,Pediatric
13500Scissors,Plastic Surgery
13501Scissors,Rectal
13502Scissors,Suture
13504Scissors,Thoracic
13507Sclerotomes
13508Scoops
13509Scoops,Gallstone
13512Scrapers,Cytology
13513Screens
13514Screens,Bedside
13517Screwdrivers,Bone
13520Scrub Dresses
13522Scrub Dresses,Disposable 13523Scrub Dresses,Reusable
13524Scrub Suits
13526Scrub Suits,Disposable
13527Scrub Suits,Reusable
13529Binders,Scultetus
13532Searchers,Mastoid
13536Sensors
13538Sensors,Oxygen UMDNS
CODE
UMDNS TERM English
13540Separators
13542Separators,Dural
13543Separators,Pylorus
13544Separators,Toe
13549Sharpeners
13550Sharpeners,Dental
13551Sharpeners,Knife
13552Sharpeners,Needle
13561Sheets
13563Shields
13564Shields,Breast
13565Shields,Bunion
13569Shields,Syringe,Radiation
13570Shields,Wound
13574Covers,Shoe
13575Covers,Shoe,Conductive
13576Shoes
13578Shoes,Conductive
13579Shoes,Corrective
13583Shroud Kits
13584Shunt Adapters
13585Shunts
13586Shunts,Arteriovenous
13589Shunts,Peritoneovenous
13594Sigmoidoscopes
13598Silicone Rubber Sheeting
13607Chairs,Sitz Bath
13608Sitz Bath Kits
13609Baths,Sitz
13613Skin Graft Cutters
13614Skin Graft Cutters,Expanded Mesh 13620Sleeves,Topical Oxygen Therapy 13621Slings
13622Slings,Arm
13623Slings,Knee
13624Slings,Leg
13625Slippers
13629Snake Bite Kits
13630Snares
13631Snares,Polyp
13632Snares,Tonsil
13633Socks
13634Socks,Fracture
13635Socks,Stump
13637Bowls,Solution
13642Sounds
13643Sounds,Urethral
13644Sounds,Uterine
13645Spatulas
13646Spatulas,Brain
13647Spatulas,Cement
13648Spatulas,Eye
13649Spatulas,Lung
13650Spatulas,Microsurgical
13651Spatulas,Middle Ear
13655Specimen Containers
13659Specimen Cutters
13662Specula,Ear
13663Specula,Eye
13664Specula,Nasal
13665Specula,Rectal
13666Specula,Vaginal
13668Speech Therapy Units
13670Sphygmocardiographs
UMDNS
CODE
UMDNS TERM English
13671Sphygmographs
13673Spine Boards
13674Spirometers
13679Spirometers,Monitoring
13680Spirometers,Diagnostic
13681Splints
13683Splints,Molded
13684Splints,Molded,Aluminum
13685Splints,Molded,Plastic
13686Splints,Padded Stays
13687Splints,Pneumatic
13688Splints,Traction
13689Splints,Vacuum
13690Splints,Wire Board
13691Basins,Sponge
13692Bowls,Sponge
13693Counters,Sponge
13695Sponges
13698Sponges,Dissector
13699Sponges,Filmated
13700Sponges,Gauze
13701Sponges,Germicidal
13702Sponges,Neuro
13703Sponges,Rayon Cellulose
13704Sponges,Ophthalmic
13705Sponges,X-ray Detectable
13706Spreader Bars
13707Spreaders
13708Spreaders,Plaster
13709Spreaders,Rib
13710Spreaders,Vein
13725Baths,Steam
13727Stereotactic Headframes
13730Sterilization Containers
13731Sterilization Process Indicators
13732Sterilization Process Indicators,Biological 13734Sterilization Process Indicators,Chemical 13735Sterilization Packaging
13737Sterilizing Units
13739Sterilizing Units,Dry Heat
13740Sterilizing Units,Ethylene Oxide
13741Germicides,Liquid,Formaldehyde
13745Sterilizing Units,Radiation
13746Sterilizing Units,Steam
13748Sterilizing Units,Vapor
13750Stethoscopes
13754Stethoscopes,Electronic
13755Stethoscopes,Mechanical
13756Stethoscopes,Ultrasonic
13762Stimulators
13763Stimulators,Acupuncture
13764Stimulators,Auditory
13765Stimulators,Aversion Conditioning
13768Stimulators,Carotid Sinus Nerve
13770Stimulators,Interdental
13775Stimulators,Neuromuscular
13780Stimulators,Tactile
13782Stimulators,Electroanalgesic,Transcutaneous Electrical Nerve
13783Stimulators,Visual
13785Stockinettes
13789Stockings,Compression
13793Stockings,Pneumatic
13796Covers,Stool UMDNS
CODE
UMDNS TERM English
13803Stopcocks
13805Strain Detectors
13806Strain Gauges
13809Straps
13810Straps,Clavicle
13812Straps,Retaining
13814Stretchers
13816Stretchers,Mobile
13818Stretchers,Portable
13820Stretchers,Transfer
13822String,Gastrointestinal
13823Strippers
13824Strippers,Artery
13825Strippers,Donor Tube
13826Strippers,Drain Tube
13827Strippers,Tendon
13828Strippers,Vein
13833Stylets
13834Stylets,Bronchial
13835Stylets,Intravenous
13836Stylets,Needle
13837Stylets,Peritoneal
13839Stylets,Urethral
13845Suction Irrigators
13846Suction Kits
13848Suction Tips
13858Supports
13861Supports,Arch
13862Supports,Arm
13873Supports,Scrotal
13880Testers,Surgical Glove
13882Surgical Head Coverings
13886Surgical Packings
13887Surgical Packs
13890Suture Bolsters
13891Suture Buttons
13892Suture Kits
13894Suture Removal Kits
13895Suture Rings
13896Sutures
13898Sutures,Catgut
13899Sutures,Collagen
13900Sutures,Cotton
13902Sutures,Linen
13904Sutures,Stainless Steel Multifilament 13905Sutures,Nylon
13906Sutures,Polyester
13907Sutures,Polyethylene
13908Sutures,Polyglycolic Acid
13909Sutures,Polypropylene Monofilament 13910Sutures,Silk
13911Sutures,Stainless Steel
13912Swabs
13913Applicators,Antiseptic,Swab
13914Swabs,Specimen Collecting
13922Syringe/Needle Adapters
13923Cutters,Syringe and Needle
13924Cleaners,Syringe
13925Crushers,Syringe and Needle 13929Syringes
13931Syringes,Anesthesia
13936Syringes,Catheter
13938Dental Syringes
13940Syringes,Hypodermic
UMDNS
CODE
UMDNS TERM English
13941Syringes,Insulin
13942Syringes,Irrigating
13945Syringes,Tuberculin
13946Binders,T
13949Tables
13951Tables,Anesthetist's
13953Tables,Autopsy
13956Tables,Blood Donor
13958Tables,Examination/Treatment
13959Tables,Instrument
13960Tables,Obstetrical
13961Tables,Operating
13962Tables,Orthopedic
13963Tables,Overbed
13964Tables,Physical Therapy
13967Tables,Traction
13969Tables,Urological
13970Tachistoscopes
13976Tanks,Full-Body
13979Tapes
13981Tapes,Cotton
13983Tapes,Umbilical
13987Physiologic Monitoring Systems,Telemetric 13988ECG Monitors,Telemetric
13990Temperature Monitors,Telemetric
13994Controllers,Temperature
13996Tenaculums
13997Tenaculums,Thyroid
13998Tenaculums,Uterine
13999Tenotomes
14002Tents
14007Test Drums
14020Thermographic Devices
14022Thermographic Devices,Infrared
14023Thermographic Devices,Liquid-Crystal 14024Thermometer Holders
14025Thermometer Kits
14027Shakers,Thermometer
14028Thermometers
14032Thermometers,Electronic
14034Thermometers,Electronic,Continuous 14035Thermometers,Electronic,Intermittent 14036Thermometers,Infrared
14038Thermometers,Mercury
14047Thoracoscopes
14051Thrombometers
14053Timers
14055Timers,Radiographic/Fluoroscopic
14056Tinnitus Therapy Units
14059Radiographic Units,Tomographic
14062Tongs
14063Tongs,Bone
14064Tongs,Skull
14066Tongue Depressors
14067Tonographs
14068Tonometers
14069Tonoscopes
14070Tonsillectomes
14071Toothbrushes
14072Tourniquets
14074Tourniquets,Pneumatic
14075Tourniquets,Cardiovascular
14077Towels,Surgical
14080Tracheal Tube Adapters UMDNS
CODE
UMDNS TERM English
14081Tracheal Tube Cuff Inflators 14082Cuffs,Tracheal Tube
14084Stylets,Tracheal Tube
14085Tubes,Tracheal
14089Cannulae,Tracheostomy
14090Tracheostomy Care Kits
14092Tracheostomy Tube Adapters 14093Tracheostomy Buttons
14094Cuffs,Tracheostomy Tube
14096Tubes,Tracheostomy
14099Tracheotomy Kits
14100Belts,Traction
14101Frames,Traction
14105Traction Units
14106Traction Units,Intermittent
14108Traction Units,Intermittent,Mobile 14109Traction Units,Static,Other 14110Traction Units,Static,Bed
14111Traction Units,Static,Chair 14113Trainers,Auditory
14115Transducers
14117Transducers,Flow
14118Transducers,Force
14119Transducers,Pressure
14121Transducers,Ultrasonic
14126Transfusion Kits
14128Recorders,Transient
14130Transilluminators
14141Treadmills
14144Tremographs
14146Trephines
14147Trephines,Bone
14148Trephines,Corneal
14149Trephines,Kidney
14150Trephines,Liver
14151Trephines,Lung
14152Trephines,Skull
14154Trocars
14155Trocars,Abdominal
14156Trocars,Amniotic
14157Trocars,Antrum
14158Trocars,Cardiovascular
14159Trocars,Gallbladder
14160Trocars,Laryngeal
14161Trocars,Thoracic
14162Trocars,Tracheal
14163Tropometers
14164Troposcopes
14168Trusses
14169Trusses,Hernia
14171Trusses,Infant
14172Trusses,Nasal
14174Clips,Fallopian Tube
14175Tubes
14182Tubes,Autoclaving
14183Tubes,Blood Collection
14187Tubes,Colon
14188Tubes,Connecting
14189Tubes,Culture
14190Tubes,Decompression
14191Tubes,Drainage
14194Tubes,Enema
14195Tubes,Esophageal
14196Tubes,Esophageal,Blakemore
UMDNS
CODE
UMDNS TERM English
14197Tubes,Esophageal,Replogle
14198Tubes,Esophageal,Sengstaken
14199Tubes,Feeding
14202Tubes,Gastrointestinal
14203Tubes,Gastrointestinal,Einhorn
14204Tubes,Gastrointestinal,Harris
14205Tubes,Gastrointestinal,Homer Smathers 14206Tubes,Gastrointestinal,Kaslow
14207Tubes,Gastrointestinal,Rehfus
14208Tubes,Gastrointestinal,Ryles
14209Tubes,Gastrointestinal Decompression,
Wangensteen
14210Tubes,Gastrointestinal Decompression 14211Tubes,Gastrointestinal Decompression,
Cantor
14212Tubes,Gastrointestinal Decompression,
Dennis
14213Tubes,Gastrointestinal Decompression,Miller-Abbott
14214Tubes,Gastrostomy
14215Tubes,Gastrostomy,Malecot
14216Tubes,Gastrostomy,Mushroom
14221Tubes,Nasogastric
14224Tubes,Nephrostomy
14225Tubes,Plasma Extractor
14226Tubes,Rebreathing
14227Tubes,Rectal
14230Tubes,Stomach Evacuator
14235Tubes,Transfer
14238Tubing
14239Tubing,Braided
14240Tubing,Conductive
14242Tubing,Flex
14243Tubing,Latex
14244Tubing,Nylon
14246Tubing,Polyethylene
14247Tubing,Polyvinyl Chloride
14252Tubing,Vinyl
14255Tuning Forks
14256Frames,Turning
14257Tweezers
14258Typoscopes
14262Detergents,Ultrasonic Cleaning System 14263Ultrasonic Cleaning Systems
14271Power Meters,Ultrasonic
14276Ultrasonic Unit Analyzers
14278Scanners,Ultrasonic
14285Ureterotomes
14286Bougies,Urethral
14287Urethrographs
14288Urethrometers
14289Urethroscopes
14290Covers,Urinal
14291Urinals
14292Urinary Catheterization/Collection Kits
14297Urinary Drainage Units
14298Urinary Collection Bags
14301Irrigation Kits,Urinary
14302Urine Strainers
14303Urine Specimen Containers
14307Urodynamic Measurement Systems
14308Uroflowmeters
14310Washers,Utensil
14313Uterine Packing Devices UMDNS
CODE
UMDNS TERM English
14317Vacuum Extractors,Obstetrical
14322Moulds,Vaginal
14323Vaginometers
14325Valves
14328Valves,Ear
14329Valves,Eye
14332Valves,Nonrebreathing
14337Valves,Positive End-Expiratory Pressure 14339Valvulotomes
14345Vectorcardiographs
14346Vein Finders
14351Pressure Alarms,Airway
14352Filters,Ventilator
14355Ventilators,Other
14359Ventilator IMV Controllers
14360Ventilators,Pressure-Cycled
14361Ventilators,Intensive Care,Neonatal/Pediatric 14364Ventriculoscopes
14367Depressors,Vessel
14369Vibrators
14371Vibrometers
14372Vibrophonocardiographs
14375View Boxes
14379Viscerotomes
14380Visual Field Plotters
14382Visual Function Analyzers
14384Visuometers
14386Vitrectomy Units
14389Voltmeters
14393Walkers
14410Ovens,Drying
14413Washer/Sterilizing Units
14421Waste-Disposal Units
14423Waste-Disposal Units,Sharps
14424Waste Receptacles
14426Waste Receptacles,Contaminated
14427Kick Buckets
14428Waste Receptacles,Radioactive
14429Water Bath Circulators
14434Water Purification Filters,Charcoal
14435Water Purification Systems,Deionization 14436Water Purification Filters,Particulate
14437Water Purification Systems,Reverse Osmosis 14438Water Purification Systems,Ultraviolet
14449Wheelchairs
14450Baths,Whirlpool
14455Wire Drivers
14457Wires,Ligature
14462Irrigation Kits,Wound
14464Wrappers,Sterile
14465Binders,Wrist
14467Xenon Systems
14472Diffractometers,X-ray
14473X-ray Film Cassette Holders
14474X-ray Film Cassettes
14475X-ray Film Dryers
14477X-ray Film Labelers
14480X-ray Film Processor Quality Control Monitors 14481X-ray Film,Sheet
14482X-ray Film,Dental
14486Screens,X-ray Film Cassette
14487Markers,X-ray
14490Shields,X-ray
14491Shields,X-ray,Apron
UMDNS
CODE
UMDNS TERM English
14493Shields,X-ray,Glove
14494Shields,X-ray,Gonadal
14498View Boxes,X-ray
15003Breathing Circuits,Ventilator
15010Air Detectors,Heart-Lung Bypass
15011Heart-Lung Bypass Unit Level Detectors 15012Heart-Lung Bypass Unit Tubing Sets 15013Cleaners
15014Analgesia Units
15015Oxygen Analyzers,Sampling
15016Aspirators,Emergency
15017Bottles,Endoscopic Wash
15018Brushes,Cytology
15019Calibrators,Anesthesia Unit
15020Calibrators,Respiratory Therapy Unit 15021Cannulae,Hemodialysis
15022Catheters,Hemodialysis
15023Catheters,Femoral
15024Chairs,Birthing
15025Clamps,Skull
15026Compresses,Cold
15027Computers,Stress Exercise
15028Cricothyrotomy Kits
15029Defibrillator/Monitors,Line-Powered 15030Flasks,Dewar
15031Hemodialysis Unit Single-Pass Converters 15032Transmitter/Receiver Systems,Telephone, EEG
15033Electrodes,Defibrillation
15034Embolization Prostheses,Intravascular 15035Filters,Steam
15036Gastrointestinal Motility Analyzers
15037Gowns,Isolation
15038Guillotines,Rib
15039Hemofiltration Units
15040Inserters,Contact Lens
15041Ligators,Umbilical
15042Manifolds,Gas
15043Manifolds,Liquid
15044Microscopes,Electron
15045Nebulizers,Nonheated
15046Oxygen Meters
15047Packers,Gauze
15048Pressure Reducers,Intraocular
15050Prostheses,Tracheal
15051Regulators,Suction,Surgical
15052Laparotomy Rings
15053Scales,Wheelchair
15054Separators,Stapes
15055Sheets,Drape
15056Covers,Shoe,Nonconductive
15057Sigmoidoscopes,Flexible
15058Sigmoidoscopes,Rigid
15059Simulators
15061Simulators,Temperature
15062Spectrometers,Mass
15063Splints,Molded,Other
15065Suture Units,Automatic
15066Swabs,Cotton
15067Synchronizers,Diagnostic Ultrasonic Unit 15068Synchronizers,Gamma Camera
15069Synchronizers,Radiographic Unit
15071Transducers,Pressure,Catheter Tip 15073Bronchoscopes,Flexible UMDNS
CODE
UMDNS TERM English
15074Bronchoscopes,Rigid
15075Laryngoscopes,Flexible
15076Laryngoscopes,Rigid
15078Aprons,Laboratory
15079Spectrophotometers,Atomic Absorption 15080Spectrophotometers,Fluorescence
15081Spectrophotometers,Infrared
15082Spectrophotometers,Ultraviolet
15083Spectrophotometers,UV/Visible
15084Spectrophotometers,Visible
15085Sponges,Laparotomy
15086Bottles,Sterile Solution
15087Stimulators,Bone Growth
15089Alcohol Analyzers
15090Amino Acid Analyzers
15091Antibiotic Susceptibility Analyzers
15092Blood Urea Nitrogen Analyzers
15093Carbon Monoxide Analyzers
15098Coagulation Analyzers,Automated
15100Electrolyte Analyzers
15101Enzyme Analyzers
15102Glucose Analyzers
15103Nitrogen Analyzers
15104Platelet Aggregation Analyzers
15105Heating Blocks
15106Baths,Freezing
15107Baths,Tissue Flotation
15108Baths,Water
15109Bilirubinometers
15110Blood Smear Makers
15111Burets
15112Counters,Cell
15113Cell Separators
15114Washers,Cell
15115Centrifuges,Blood Bank
15116Centrifuges,Floor
15117Centrifuges,Refrigerated
15118Chloridometers
15119Chromatography Columns
15120Chromatography Equipment,Column,Gas 15121Chromatography Equipment,Column,Liquid 15122Chromatography Equipment,Paper,Liquid 15123Chromatography Equipment,Thin-Layer, Liquid
15124Information Systems,Laboratory
15125Counters,Bacteria
15126Counters,Colony
15127Cryogenic Blood Banking Equipment
15128Iontophoresis Units,Sweat Test
15129Densitometers
15130Desiccators
15131Dialyzers,Serum/Urine
15132Counters,Cell,Differential
15133Diluters
15134Dispensers,Paraffin
15135Dispensers,Slide
15136Distilling Units
15137Electrodes,pH
15138Electrophoresis Equipment
15139Evaporators
15140Filter Papers
15141Fluorometers
15142Collectors,Fraction
15143Thyroid Function Units
UMDNS
CODE
UMDNS TERM English
15144Freezers,Blood Plasma
15145Freezers,Laboratory
15146Hemoglobinometers
15148Hoods,Microbiological
15149Immunodiffusion Equipment 15150Immunofluorescence Equipment 15151Incubators,Aerobic
15152Incubators,Anaerobic
15153Labware,Basic
15154Lifts,Mortuary
15155Loops,Inoculating
15156Microscopes,Laboratory,Light 15157Microtomes,Cryostat
15158Microtomes,Rotary
15159Microtomes,Sliding
15160Microtomes,Ultra
15161Mixers,Clinical Laboratory 15162Freezer Monitors
15163Nephelometers
15164pH Meters
15165Photometers
15166Pipettes
15167Extractors,Plasma
15168Pumps,Laboratory
15169Refractometers,Laboratory 15170Refrigerators,Biologic
15171Refrigerators,Blood Bank 15172Refrigerators,Explosion-Proof 15173Rotators
15174Saws,Autopsy
15175Scales,Laboratory
15177Sedimentation Rate Units 15178Shakers,Laboratory
15179Sharpeners,Microtome Knife 15180Sinks,Dissecting
15182Slide Stainers,Hematology 15183Slide Stainers,Histology
15184Counters,Scintillation
15185Slides,Microscope
15186Racks,Test Tube
15187Test Tubes
15188Tissue Culture Apparatus 15189Tissue Embedding Equipment 15190Tissue Processors
15191Titrators
15192Tubes,Capillary
15193Ultracentrifuges
15195View Boxes,Rh Typing
15196Washers,Labware
15197Washers,Pipette
15198Washers
15200Oximeters,Intracardiac
15201Oximeters,In Vitro
15202Anesthesia Kits,Other
15203Bandages,Other
15204Burs,Other
15205Cabinets,Other
15206Cannulae,Other
15207Cardiac Output Units,Other 15208Carts,Other
15209Catheters,Other
15210Chairs,Other
15211Chisels,Other
15212Clamps,Other UMDNS
CODE
UMDNS TERM English
15213Clips,Other
15214Cushions,Other
15215Dilators,Other
15216Dressings,Other
15217Electrodes,Other
15218Elevators,Other
15219Ergometers,Other
15220Exercisers,Other
15221Forceps,Other
15222Gloves,Other
15223Gowns,Other
15224Guides,Other
15225Hooks,Other
15226Knives,Other
15228Lights,Other
15229Mallets,Other
15230Masks,Other
15231Masks,Air-Oxygen,Other
15233Heart Rate Monitors,Other
15234Needles,Other
15235Osteotomes,Other
15236Perforators,Other
15237Probes,Other
15238Probes,Eye,Other
15239Punches,Other
15240Rasps,Other
15242Retractors,Other
15243Rongeurs,Other
15244Saws,Other
15245Scissors,Other
15246Scissors,Eye,Other
15247Snares,Other
15248Sounds,Other
15249Spatulas,Other
15250Specula,Other
15251Splints,Other
15252Sponges,Other
15253Spreaders,Other
15254Strippers,Other
15255Sutures,Other
15256Syringes,Other
15257Tables,Other
15258Tenaculums,Other
15259Trephines,Other
15260Trocars,Other
15261Tubes,Esophageal,Other
15262Tubes,Gastrointestinal,Other
15263Tubes,Gastrointestinal Decompression,Other 15264Tubes,Gastrostomy,Other
15265Tubing,Other
15266Shields,X-ray,Other
15267Phantoms,Nuclear Medicine
15268Filters,Radio-Frequency
15269Magnets,Eye
15270Drains,Sump
15271Transmitter/Receiver Systems,Telephone, ECG
15272Incubators,Test Tube,Portable
15273Incubators,Test Tube,Stationary
15274Amniocentesis Kits
15275Awls
15276Ampules
15277Tubing,Silicone
15278Tubes,Other
UMDNS
CODE
UMDNS TERM English
15279Laminar Air Flow Units,Fixed
15280Laminar Air Flow Units,Mobile
15281Sponges,Scrub
15283Filters,Syringe
15284Injectors,Contrast Media,Angiography 15285Injectors,Contrast Media,Lymphangiography 15286Syringes,Angiography
15287Screens,Anesthesia
15288Entoptoscopes
15289Nephroscopes,Flexible
15290Nephroscopes,Rigid
15292Pillows,Cervical
15293Domes,Pressure Transducer
15295Scanners,Long-Term Recording,ECG 15296Transducer Holders
15297Timers,Coagulation
15299Iron Analyzers
15300Lead Ion Analyzers
15301Radioimmunoassay Analyzers
15302Spectrometers,Nuclear Magnetic Resonance 15303Titrators,Calcium
15304Homogenizers,Tissue
15305Mixers,Blood Bank,Donor Blood
15306Microbiological Systems,Automated
15308Cables,Fiberoptic
15309Training Manikins,Cardiopulmonary
Resuscitation
15310Urinometers
15311Mounts,Monitor
15312Timers,Other
15313Culdocentesis Kits
15314Suction Tips,Electrosurgical
15315Tubes,Blood,Microcollection
15316Arthrogram Kits
15318Wound Drainage Kits,Closed,Craniotomy 15319Dressings,Skin Graft,Donor-Site
15320Catheter Flush Valves,Continuous
15321Gel,Ultrasonic Coupling
15322Tubes,Bronchial
15323Tubes,Myringotomy
15324Prostheses,Eustachian Tube
15325Vacuum Stabilized Pads
15326Exercisers,Wrist
15327Incubators,Test Tube
15550Alarms
15551Clinical Chemistry Analyzers
15552Coagulation Analyzers
15553Aprons
15554Basins
15555Baths
15556Belts
15557Binders
15558Blades
15559Bottles
15560Bougies
15561Bowls
15562Breathing Circuits
15563Calibrators
15564Catheterization Kits
15565Cement
15566Chambers
15567Charts
15568Chromatography Equipment
15569Clippers UMDNS
CODE
UMDNS TERM English
15571Covers
15572Cups
15573Cutters
15574Metal Detectors
15575Dialysate Delivery Systems
15576Droppers
15577Dynamometers
15578Electrodes
15579Electrodes,Electrosurgical
15580Extractors
15581Forensic Evidence Kits,Other
15582Frames
15583Freezers
15584Gel
15585Irrigation Kits
15586Jars
15587Manifolds
15588Microscopes,Laboratory
15589Microtomes
15590Mixers
15591Nephroscopes
15592Oxygenators
15593Pillows
15594Racks
15595Recorders
15596Sampling Kits
15597Scoops,Common Duct
15598Shakers
15599Slide Stainers
15600Spectrometers
15601Spectrophotometers
15602Specula
15604Synchronizers
15605Testers
15606Testers,Power,Receptacle
15607Traction Units,Static
15608Traps
15609Trays
15610Warmers
15611Water Purification Filters
15612Water Purification Systems
15613Ventilators
15614Nurse Call Systems
15615Vacuum Pumps,Central
15616Headwall Systems,Prefabricated
15617Patient Service Consoles
15618Tracks and Carriers
15619Tracks and Carriers,Cubicle Curtain
15620Tracks and Carriers,Intravenous
15621Microsurgical Instruments
15622Injectors,Uterine
15623Contact Lens Removers
15624Dressings,Tracheostomy Tube
15625Papillotomes
15627Spectrum Analyzers,Audio
15628Forceps,Grasping,Flexible Endoscopic 15629Retrieval Baskets,Biliary Stone
15630Vaginoscopes
15631Stimulator Analyzers,Transcutaneous Nerve 15632Tinnitus Masker Analyzers
15633Hearing Aid Analyzers
15634Middle Ear Analyzers
15635Retractors,Fiberoptic-Illuminated
15636Suction Tips,Fiberoptic-Illuminated
UMDNS
CODE
UMDNS TERM English
15638Lift Height Evaluation Units
15639Paper,Recording
15640Pressure Monitoring Tubing Sets
15642Immobilizers,Cervical
15643Drapes,Instrument
15645Humidifiers,Heat/Moisture Exchange 15646Drapes,Surgical,Disposable
15647Drapes,Surgical,Reusable
15648Timers,Apgar Scoring
15649Filters,Gas
15650Timers,Phototherapy
15651Stirrers
15652Loupes
15653Magnifiers,Operating
15654Forms,Medical and Patient
15656Scanners,Ultrasonic,Mammographic 15657Scanners,Ultrasonic,Obstetric/Gynecologic 15659Scanners,Ultrasonic,Other
15660Lights,Overbed
15661Sheets,Examination Table
15662Massage Machines,Physical Therapy 15663Pipetters
15664Controllers,Temperature,Humidifier 15665Controllers,Temperature,Other
15666Training Manikins
15667Training Manikins,Other
15668Tubing,Nonconductive
15669Rongeurs,Intervertebral Disk
15670Forceps,Bone
15671Clamps,Rectal
15672Forceps,Tonsil
15673Hooks,Rectal
15674Punches,Ear
15675Retractors,Mastoid
15676Snares,Nasal
15677Elevators,Uterine
15678Computers,Nuclear Medicine
15679Needles,Tine Test
15680Labware,Basic,Reusable
15681Labware,Basic,Disposable
15682Tubes,Centrifuge
15683Cuvettes,Spectrophotometer
15684Transmitter/Receiver Systems,Telephone, ECG,Single-Channel
15685Transmitter/Receiver Systems,Telephone, ECG,Multichannel
15686Laboratory Safety Equipment
15687Cover Glass,Microscope Slide
15688Filters,Shunt,Hydrocephalic
15689Applicators,Other
15690Chairs,Adjustable Height
15691Pressure Pads,Soft Rubber
15692Spuds,Eye,Electric
15693Patient Transfer Aids
15695Charts,Acupuncture
15697Eyewear,Safety
15698Cabinets,Microbiological
15699Covers,Heel Stirrup
15700Heel Stirrup Pads
15701Dishes,Petri
15702Crutch Tips,Rubber
15704Dressings,Occlusive
15705Sheets,Drape,Disposable
15706Sheets,Drape,Reusable UMDNS
CODE
UMDNS TERM English
15707Sheets,Operating Room,Disposable 15708Sheets,Operating Room,Reusable
15709Blood Gas/pH Analyzers
15710Forceps,Dental
15711Punches,Dental,Rubber Dam
15712Clamps,Dental,Rubber Dam
15713Rongeurs,Dental
15714Centrifuge Tube Adapters
15715Bibs,Obstetrical
15718X-ray Film Minifiers
15719EEG Monitors,Telemetric
15720EMG Monitors,Telemetric
15721EOG Monitors,Telemetric
15723Chairs,Examination/Treatment,Ophthalmic 15724Cabinets,Head/Neck Treatment
15726Stretchers,Radiographic
15731Phototherapy Units,Ultraviolet
15732Beds,Birthing
15733Scrub Machines,Surgical
15734Urologic Hangers
15735Catheter Tube Holders
15737Rhinomanometers
15738Sheets,Examination Table,Disposable 15739Sheets,Examination Table,Reusable 15740Eyeglasses,Aphakic
15741Rasps,Bone
15742Mailers
15743Mailers,Specimen Container,Insulated 15744Mailers,Specimen Container
15745Mailers,Slide
15747Speech Amplifiers
15748Cameras,Endoscopic
15749Covers,Bur Hole
15750Pill Crushers/Splitters
15751Shielding,Magnetic Field
15752Shields,Heat,Infant
15753Transmitter/Receiver Systems,Telephone, Physiologic Monitor
15754Cables/Leads,ECG
15756Aspirators,Ultrasonic
15757Lasers,Surgical
15759Microscope Contrast Enhancement Units 15760Beds,Electric,Obese
15762Lights,Ultraviolet,Other
15764Covers,Footswitch
15765Covers,Camera
15766Orthopedic Internal Fixation Systems,Spinal 15767Orthopedic External Fixation Systems,
Fracture
15768Cannulae,Aortic
15770Radiographic Quality Assurance Devices 15771Pacers,Counting,Cardiopulmonary
Resuscitation
15772Lubricants,Instrument
15774Blades,Cast Cutter
15775Drapes
15776Blood Potassium Monitors
15777Trays,Skin Scrub
15778Covers,Clamp
15779Cages,Animal
15780Timers,Radiotherapy Unit
15781Infusion Systems,Insulin,Closed-Loop 15783Ventilators,High-Frequency
15784Stents
UMDNS
CODE
UMDNS TERM English
15785Calibrators,Infusion Drop-Rate
15786Package Sealers
15787Sphincteroscopes
15788Ureteroscopes
15790Lumboscopes
15791Physiologic Monitoring Systems,Neonatal 15792Paging Systems,Other
15793Stretchers,Orthopedic
15794Scleral Buckling Devices
15795Cardiac Output Units,Radioisotope
15796Knives,Plasma
15797Laundry Bags,Infection Control
15798Trays,Food,Disposable
15799Trays,Food,Reusable
15800Forceps,Dissecting
15801Jaw Fracture Fixation Devices
15802Trays,Food
15803Laundry Bags,Other
15806Dressings,Periodontal
15808Containers,Evacuated
15809Bottles,Evacuated
15810Accelerometers
15811Anatomical Models
15812Cabinets,Drying
15813Cabinets,Formaldehyde
15814Cabinets,Laboratory
15815Cameras,Microscope
15816Training Arms,Intravenous
15817Isolated Power Systems
15818Cyclotrons
15819X-ray Film Cutters
15820Radioactive Sources
15821Contrast Media,Radiographic/Fluoroscopic 15822Silver Recovery Systems
15823Cameras,Multi-Image
15824Alarms,Central Gas System
15825Baths,Dialysate Warming
15826Diplopiometers
15827Dispensers,Soap
15828Racks,Drying
15829Extrication Devices
15830Floor Coatings,Conductive
15831Floor Mats
15832Flooring,Conductive
15833Ground Continuity Monitors
15834Grounding Devices,Antistatic
15835Grounding Systems
15836Covers,Hamper
15837Hamper Liners
15838Hamper Stands
15839Hampers
15840Paging Systems
15841Paging Systems,Public Address
15845Pantographs
15846Physician In/Out Registries
15847Plugs
15848Plugs,Explosion-Proof
15849Plugs,Ground
15850Plugs,Hospital Grade
15851Plugs,Locking
15852Rails
15853Rails,Bathtub
15854Rails,Commode
15855Rails,Wall UMDNS
CODE
UMDNS TERM English
15856Receptacles
15857Receptacles,Explosion-Proof
15858Receptacles,Ground
15859Receptacles,Hospital Grade
15860Receptacles,Locking
15861Television Sets,Hospital
15862Vials,Medication
15863Alarms,Voltage
15864Basins,Wash
15865Wound Moulages
15866Lights,Examination,Ceiling-Mounted 15867Brushes,Intramedullary
15868Needle Guides
15869Prostheses,Cardiac Valve,Artificial 15870Prostheses,Cardiac Valve,Biological 15871Shields,X-ray,Eye
15872Shields,X-ray,Portable
15873Sutures,Iodized
15874Diathermy Units,Ophthalmic
15875Prism Bars
15876Occluders,Ophthalmic
15877Probes,Microlaryngeal
15878Clamps,Carotid
15879Clamps,Coarctation
15881Clamps,Pediatric
15882Clamps,Vascular
15883Burs,Microsurgical
15884Irons,Brace Bending
15885Catheters,Dye Dilution
15886Carts,Central Supply
15887Carts,Food Service
15888Carts,Linen/Laundry
15889Carts,Service/Utility
15890Carts,Housekeeping
15891Carts,Surgical Case
15892Helium Analyzers
15893Acoustical Casewalls
15894Acoustical Rooms
15895Casework
15896Casework,General-Purpose
15897Casework,Laboratory
15898Casework,Modular
15899Casework,Nursing Station
15900Casework,Patient Room
15901Casework,Pharmacy
15903Medical Chart Holder Accessories 15904Compactors
15905Compactors,Fixed
15906Compactors,Portable
15907Corner Guards
15908Curtains,Shower
15909Curtains,Shower,Antibacterial 15910Curtains,Shower,Disposable
15911Curtains,Shower,Reusable
15912Dispensers,Ice
15913Freezers,Bone
15914Freezers,Eye Bank
15915Furniture,Patient Room
15916Laundry Equipment
15917Nourishment Stations
15918Radio-Frequency-Free Rooms 15920Refrigerators,Eye Bank
15921Refrigerators,Food,Reach-in
15922Refrigerators,Food,Walk-in
欧盟医疗器械的分类规则(93/42 EEC ) 第1条: 不接触病人或仅接触未受损皮肤类器械 规则的一般解释 本规则是所有无更具体规则规范的器械的后备规则。 此规则通常适用于那些仅与未受损皮肤接触或与病人无接触的器械。 Rule 1 Examples 除非适用于以下列出的其他规则,所有非侵入 式器械都属于I 类 -用于防止体液回流的收集设备(例如用于收集人体废物的尿液收集瓶(urine collection bottles),造瘘袋(ostomy pouches),大小便失禁垫(incontinence pads)或伤口引流 设备(collectors used with wound drainage devices))。这 些装置可能通过导管和管道与患者连接。 - 用于固定身体部位或对身体部位施压的装置(如有助于扭伤愈合的非灭菌敷料,熟石膏,颈椎项圈,重力牵引装置,压缩针织品等)(non-sterile dressings used to aid the healing of a sprain, plaster of Paris, cervical collars, gravity traction devices, compression hosiery) - 一般用于患者外部支持的设备(如病床(hospital beds),病人吊(patient hoists),助行器(walking aids),轮椅(wheelchairs),担架(stretchers),牙科病人椅(dental patient chairs) - 矫正用眼镜和镜框(corrective glassed and frames) - 诊断用听诊器(stethoscopes for diagnosis) - 眼部闭塞膏药(eye occlusion plasters) - Incision drapes - 导电胶(incision drapes) - 非侵入性电极(用于脑电图或心电图的电极) Non-invasive electrodes (electrodes for EEG Or ECG) - 图像增感屏(image intensifying screens) - 用于清除眼部杂物的永磁体(permanent magnets for removal of ocular debris) 分类的实际问题 一些以间接方式与人体接触的非侵入性器械,通过血液,其他体液或重新进入人体的液体的存储、输送、处理或通过能量传递到人体的的方式影响人体内部的生理过程。这些器械不在此规则的适用范围之内。因这类器械以间接方式对人体内产生危害,其分类受另外规则的规范。 S G S
COMMISSION REGULATION (EU) No 207/2012 of 9 March 2012 on electronic instructions for use of medical devices (Text with EEA relevance) THE EUROPEAN COMMISSION, Having regard to the Treaty on the Functioning of the European Union, Having regard to Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices ( 1 ), and in particular Article 9(10) thereof, Having regard to Council Directive 93/42/EEC of 14 June 1993 concerning medical devices ( 2 ), and in particular Article 11(14) thereof, Whereas: (1) For some medical devices the provision of instructions for use in electronic form instead of in paper form can be beneficial for professional users. It can reduce the environmental burden and improve the competitiveness of the medical devices industry by reducing costs, while maintaining or improving the level of safety. (2) Such possibility of providing instructions for use in elec - tronic form instead of in paper form should be limited to certain medical devices and accessories intended to be used in specific conditions. In any case, for reasons of safety and efficiency users should always have the possi -bility to obtain those instructions for use in paper form on request. (3) In order to reduce potential risks as far as possible, the appropriateness of the provision of instructions for use in electronic form should be subject to a specific risk assessment by the manufacturer. (4) In order to ensure that users have access to the instructions for use, appropriate information about access to those instructions for use in electronic form and about the right to request the instructions for use in paper form, should be provided. (5) To ensure unconditional access to the instructions for use in electronic form and to facilitate the communication of updates and of product alerts, the instructions for use in electronic form should also be available through a website. (6) Regardless of the language obligations imposed on manufacturers by the law of the Member States, manu -facturers who provide instructions for use in electronic form should indicate on their website in which Union languages those instructions are available. (7) Except for medical devices of Class I, as defined in Annex IX to Directive 93/42/EEC, the fulfilment of the obligations laid down in this Regulation should be reviewed by a notified body during the procedure applicable for conformity assessment based on a specific sampling method. (8) As the protection of the right to privacy of natural persons with respect to the processing of personal data should be ensured by manufacturers and notified bodies as well, it is appropriate to provide that websites containing instructions for use of a medical device fulfil the requirements of Directive 95/46/EC of the European Parliament and of the Council of 24 October 1995 on the protection of individuals with regard to the processing of personal data and on the free movement of such data ( 3 ). (9) In order to ensure safety and consistency, instructions for use in electronic form which are provided in addition to complete instructions for use in paper form should be covered by this Regulation as regards limited requirements in relation to their contents and websites. (10) It is appropriate to provide for a deferred application of this Regulation so as to facilitate the smooth transition to the new system and to allow all operators and Member States time to adapt to it. (11) The measures provided for in this Regulation are in accordance with the opinion of the Committee set up by Article 6(2) of Directive 90/385/EEC, HAS ADOPTED THIS REGULATION: Article 1 This Regulation establishes the conditions under which the instructions for use of medical devices referred to in point 15 of Annex 1 to Directive 90/385/EEC and in point 13 of Annex I to Directive 93/42/EEC may be provided in electronic form instead of in paper form. It also establishes certain requirements concerning instructions for use in electronic form which are provided in addition to complete instructions for use in paper form relating to their contents and websites. Article 2 For the purposes of this Regulation, the following definitions shall apply: (a) ‘instructions for use’ means information provided by the manufacturer to inform the user of the device of its safe and proper use, of its expected performances and of any ( 1 ) OJ L 189, 20.7.1990, p. 17. ( 2 ) OJ L 169, 12.7.1993, p. 1. ( 3 ) OJ L 281, 23.11.1995, p. 31.
入欧盟的相关知识 一、欧盟国家(共31 家) 1、2004 年5 月1 日前:法国、德国、意大利、荷兰、比利时、卢森堡、丹麦、爱尔兰、英国、希腊、西班牙、葡萄牙、奥地利、芬兰、瑞典; 2、2004 年5 月1 日加入:波兰、匈牙利、捷克、斯洛伐克、斯洛文尼亚、爱沙尼亚、拉脱维亚、立陶宛、塞浦路斯、马耳他; 3、欧洲自由贸易协会EFTA :挪威、列支敦士登、冰岛、瑞士; 4、新入欧盟:罗马利亚、保加利亚; 5、瑞士不要求产品携带CE 标志。 二、医疗器械CE 认证的通用要求 1、基本要求(总要求) (1 )安全性(任何风险与器械提供的益处相比较,必须在可以接受的范围内,故亦称风险分析); (2 )风险的可预防性或被消除性,至少应给予警告(报警系统或警戒报警系统); ( 3 )性能符合性(产品的基本要求); (4 )器械性能和安全的效期(器械的安全和性能必须在器械的使用寿命内得到保证。); (5 )器械的储存和运输(应保证器械在合理的运输、储存条件下不受影响)。 2、基本要求的具体包括如下14 条: (1 )器械设计和生产必须保证:按照其预定和条件使用,器械不会损害医疗环境、患者安全、操作者或其他人员的安全和健康;使用时的潜在危险与患者受益相比较可以为人们所接受,但应具有高水平的防护办法。 (2 )生产者的设计和制造方案,必须考虑在现有工艺技术条件下遵守安全准则、生产者应: 首先应尽可能降低甚至避免危险。 其次,对无法避免的危险采取适当的防护措施,包括安装报警装置;最后,告知用户所提供防护措施的弱点及其可能带来的危险。 ( 3 )器械必须取得生产者期望获得的功能。器械设计制造和包装应有利于第一条(2) (A)D 多规定的各项功能的发挥。 (4 )在生产线者确定的器械使用寿命期内,在正常使用可能出现的压力,第1、 2 、 3 款所指的各项性 能应保持稳定,不能危害医疗环境、危害患者、使用者或其他人员的健康。 (5 )器械的设计、生产和包装应当保证,器械的性能在运输和储存过程中只要遵守有关规定不会发生根本逆变。 (6)副作用的大小同器械的使用性能相比较可以为人们所接受。 (7 )化学、物理和生物性能 (8)感染和微生物污染。 (9)组装和环境因素 (10 )检测器械 (11 )辐射防护 (12 )带有能源或与其他能源相连接的器械
企业质量考核所需备案之各医疗器械标准 1.医用电气设备第一部分:安全通用要求-GB 9706.1-1995 2.医用电气设备第一部分:安全通用要求 1.并列标准:医用电气系统安全要求-GB 9706.15-1999 3.医用有机硅材料生物学评价试验方法-GB/T 16175-1996 4.医疗器械生物学评价第1部分:评价与试验-GB/T 16886.1-2001 5.编写和使用医用电气设备教材的导则-GB/Z 17994-1999 6.管理、医疗、护理人员安全使用医用电气设备导则-GB/T 17995-1999 7. 医疗保健产品灭菌生物指示物第1部分:通则-GB 18281.1-2000 8. 最终灭菌医疗器械的包装-GB/T 19633-2005 9. .医疗器械产品图样及设计文件的术语-YY/T 0047-91 10. 医疗器械产品工作图样的基本要求-YY/T 0048-91 1 1. 医疗器械产品图样及设计文件格式-YY/T 0049-91 12医疗器械产品图样及设计文件编号原则-YY/T 0050-91 13. 医疗器械产品图样及其主要设计文件的完整性-YY/T 0051-91 14. 医疗器械产品图样及设计文件的更改办法-YY/T 0052-91 15. 医疗仪器设备用产品铭牌-YY/T 0083-92 16. 质量体系医疗器械GB/T 19002-ISO 9002应用的专用要求-YY/T 0288-1996 17. 医疗器械风险管理对医疗器械的应用-YY/T 0316-2003 18. 医疗器械用于医疗器械标签、标记和提供信息的符号-YY 0466-2003 19. 医疗器械保障医疗器械安全和性能公认基本原则的标准选用指南-YY/T 0467-2003 20. 命名用于管理资料交流的医疗器械命名系统规范-YY/T 0468-2003
入欧盟的相关知识 一、欧盟国家(共31家) 1、2004年5月1日前:法国、德国、意大利、荷兰、比利时、卢森堡、丹麦、爱尔兰、英国、希腊、 西班牙、葡萄牙、奥地利、芬兰、瑞典; 2、2004年5月1日加入:波兰、匈牙利、捷克、斯洛伐克、斯洛文尼亚、爱沙尼亚、拉脱维亚、立陶宛、塞浦路斯、马耳他; 3、欧洲自由贸易协会EFTA:挪威、列支敦士登、冰岛、瑞士; 4、新入欧盟:罗马利亚、保加利亚; 5、瑞士不要求产品携带CE标志。 二、医疗器械 CE认证的通用要求 1、基本要求(总要求) (1)安全性(任何风险与器械提供的益处相比较,必须在可以接受的范围内,故亦称风险分析); (2)风险的可预防性或被消除性,至少应给予警告(报警系统或警戒报警系统); (3)性能符合性(产品的基本要求); (4)器械性能和安全的效期(器械的安全和性能必须在器械的使用寿命内得到保证。); (5)器械的储存和运输(应保证器械在合理的运输、储存条件下不受影响)。 2、基本要求的具体包括如下14条: (1)器械设计和生产必须保证:按照其预定和条件使用,器械不会损害医疗环境、患者安全、操 作者或其他人员的安全和健康;使用时的潜在危险与患者受益相比较可以为人们所接受,但应具有高 水平的防护办法。 (2)生产者的设计和制造方案,必须考虑在现有工艺技术条件下遵守安全准则、生产 者应:首先应尽可能降低甚至避免危险。 其次,对无法避免的危险采取适当的防护措施,包括安装报警装 置;最后,告知用户所提供防护措施的弱点及其可能带来的危险。 (3)器械必须取得生产者期望获得的功能。器械设计制造和包装应有利于第一条(2) (A)D多规定的各项功能的发挥。 (4)在生产线者确定的器械使用寿命期内,在正常使用可能出现的压力,第1、2、3款所指的各项性能 应保持稳定,不能危害医疗环境、危害患者、使用者或其他人员的健康。 (5)器械的设计、生产和包装应当保证,器械的性能在运输和储存过程中只要遵守有关规定不会 发生根本逆变。 (6)副作用的大小同器械的使用性能相比较可以为人们所接受。 (7)化学、物理和生物性能 (8)感染和微生物污染。 (9)组装和环境因素 (10)检测器械 (11)辐射防护 (12)带有能源或与其他能源相连接的器械 (13)生产者提供的操作信息 (14)如果需要根据医疗数据确定器械是否满足基本要求,如第六款的情形,有关数据必须按照附录Ⅹ
入欧盟的相关知识一、欧盟国家(共31家) 1、2004年5月1日前:法国、德国、意大利、荷兰、比利时、卢森堡、丹麦、爱尔兰、英国、希腊、西班牙、葡萄牙、奥地利、芬兰、瑞典; 2、2004年5月1日加入:波兰、匈牙利、捷克、斯洛伐克、斯洛文尼亚、爱沙尼亚、拉脱维亚、立陶宛、塞浦路斯、马耳他; 3、欧洲自由贸易协会 EFTA:挪威、列支敦士登、冰岛、瑞士; 4、新入欧盟:罗马利亚、保加利亚; 5、瑞士不要求产品携带CE标志。 二、医疗器械CE认证的通用要求 1、基本要求(总要求) (1)安全性(任何风险与器械提供的益处相比较,必须在可以接受的范围内,故亦称风险分析);(2)风险的可预防性或被消除性,至少应给予警告(报警系统或警戒报警系统); (3)性能符合性(产品的基本要求); (4)器械性能和安全的效期(器械的安全和性能必须在器械的使用寿命内得到保证。); (5)器械的储存和运输(应保证器械在合理的运输、储存条件下不受影响)。 2、基本要求的具体包括如下14条: (1)器械设计和生产必须保证:按照其预定和条件使用,器械不会损害医疗环境、患者安全、操作者或其他人员的安全和健康;使用时的潜在危险与患者受益相比较可以为人们所接受,但应具有高水平的防护办法。 (2)生产者的设计和制造方案,必须考虑在现有工艺技术条件下遵守安全准则、生产者应: 首先应尽可能降低甚至避免危险。 其次,对无法避免的危险采取适当的防护措施,包括安装报警装置; 最后,告知用户所提供防护措施的弱点及其可能带来的危险。 (3)器械必须取得生产者期望获得的功能。器械设计制造和包装应有利于第一条(2) (A)D多规定的各项功能的发挥。 (4)在生产线者确定的器械使用寿命期内,在正常使用可能出现的压力,第1、2、3款所指的各项性能应保持稳定,不能危害医疗环境、危害患者、使用者或其他人员的健康。 (5)器械的设计、生产和包装应当保证,器械的性能在运输和储存过程中只要遵守有关规定不会发生根本逆变。 (6)副作用的大小同器械的使用性能相比较可以为人们所接受。 (7)化学、物理和生物性能 (8)感染和微生物污染。 (9)组装和环境因素 (10)检测器械 (11)辐射防护 (12)带有能源或与其他能源相连接的器械 (13)生产者提供的操作信息 )如果需要根据医疗数据确定器械是否满足基本要求,如第六款的情形,有关数据必须按照附录Ⅹ14(. 的规定取得 三、申请CE认证 (一)一般流程(所有的产品)
医疗器械标志、标签要求 医疗器械处黄荣建 二〇〇六年三月 一、范围 为医疗器械的安全和有效使用,给使 用者和其他人员规定了用于提供医疗器械 重要信息的标志、标识,主要由下列人员使 用。 ???? 医疗器械制造商 ???? 医疗器械使用者 ???? 负责医疗器械产品上市后监督的人员 ???? 主管部门、检测机构、认证机构等 二、依据 ???? 法律、法规 《医疗器械监督管理条例》 《医疗器械说明书、标签、包装标识》 ???? 国家标准、行业标准 通用标准 专用标准 产品标准 ???? 企业标准(注册产品标准) 标识、标签和使用说明书。 附录A安全要求中“外部标记”。(医用电气产 品) 通用标准 ?GB/T191-2000《包装储运图示标志》
?YY0466-2003《医疗器械用于医疗器械标签、标记和提供信息的符号》 ?YY/T0313-1998《医用高分子制品包装、标志、运输和贮存》?GB9706.1-1995《医用电气设备第一部分:安全通用要求》 ?YY91099-1999《医用X线设备标志、包装、运输和贮存》 专用标准 ?YY0089-1992《病人监护系统专用安全要求》 ?YY0319-2000《医用电气设备第二部分:医疗诊断用磁共振设备安全专用要求》 ?GB9706.X-XXXX《医用电气设备第X部分:XX设备安全专用要求》 ?YY0290.4-1997《人工晶体第4部分:标签和资料》 ?YY/T0486-2004《激光手术专用气管插管标志和提供信息的要求》 产品标准 ?GB8369-2005《一次性使用输血器》 ?GB10152《B型超声诊断设备》 ?YY0460-2003《超声洁牙设备》 医用高分子制品标志 ?单包装或初包装宜有下列标志: —产品名称、型号或规格; —制造厂名称、地址和商标; —生产批号或日期。 ?无菌产品的单包装或初包装还宜有下列标志:
医疗器械进入欧盟医疗器械市场要求 入欧盟的相关知识 一、欧盟国家(共31 家) 1、2004 年5 月1 日前:法国、德国、意大利、荷兰、比利时、卢森堡、丹麦、爱尔兰、英国、希腊、西班牙、葡萄牙、奥地利、芬兰、瑞典; 2、2004 年5 月1 日加入:波兰、匈牙利、捷克、斯洛伐克、斯洛文尼亚、爱沙尼亚、拉脱维亚、立陶宛、塞浦路斯、马耳他; 3、欧洲自由贸易协会EFTA :挪威、列支敦士登、冰岛、瑞士; 4、新入欧盟:罗马利亚、保加利亚; 5、瑞士不要求产品携带CE标志。 二、医疗器械CE认证的通用要求 1、基本要求(总要求) (1)安全性(任何风险与器械提供的益处相比较,必须在可以接受的范围内,故亦称风险分析); (2)风险的可预防性或被消除性,至少应给予警告(报警系统或警戒报警系统); (3)性能符合性(产品的基本要求); (4)器械性能和安全的效期(器械的安全和性能必须在器械的使用寿命内得到保证。); (5)器械的储存和运输(应保证器械在合理的运输、储存条件下不受影响)。 2、基本要求的具体包括如下14 条: (1)器械设计和生产必须保证:按照其预定和条件使用,器械不会损害医疗环境、患者安全、操作者或其他人员的安全和健康;使用时的潜在危险与患者受益相比较可以为人们所接受,但应具有高水平的防护办法。 (2)生产者的设计和制造方案,必须考虑在现有工艺技术条件下遵守安全准则、生产者应: 首先应尽可能降低甚至避免危险。 其次,对无法避免的危险采取适当的防护措施,包括安装报警装置;最后,告知用户所提供防护措施的弱点及其可能带来的危险。 (3)器械必须取得生产者期望获得的功能。器械设计制造和包装应有利于第一条(2) (A)D 多规定的各项功能的发挥。 (4)在生产线者确定的器械使用寿命期内,在正常使用可能出现的压力,第1、2、3款所指的各项性能应保持稳定,不能危害医疗环境、危害患者、使用者或其他人员的健康。 (5)器械的设计、生产和包装应当保证,器械的性能在运输和储存过程中只要遵守有关规定不会发生根本逆变。 (6)副作用的大小同器械的使用性能相比较可以为人们所接受。 (7)化学、物理和生物性能 (8)感染和微生物污染。
医疗器械注册专员培训 YZB 标准名称 (企业单位名称)发布
前言 XXX产品是我公司开发的新产品。目前该产品尚无国家标准、行业标准,为规范产品的技术特性,确保产品的安全有效,特制订本注册产品标准,做为生产质量控制的依据。 XXX产品注册产品标准引用了GB191《包装储运图示标志》,GBT14710《医用电气设备环境要求及试验方法》,GB9706.1《医用电气设备第一部分:安全通用要求》等标准中的内容。本标准的安全要求全面贯彻了GB9706.1—1995。并将其列入本标准附录A(规范性附录)。 本标准的附录A是规范性附录 本注册标准由天津市XXXXXXX公司提出并负责起草。 本注册标准主要起草人:XXX。 本注册标准首次发布于200X年XX月。 本注册标准由天津市XXXX(企业名称)法定代表人批准,并对所规定的内容负责。
标准名称 1 范围 本标准规定了XXX产品的结构和基本参数、要求、试验方法、检验规则、标志、包装、运输、贮存。 本标准适用于XXX产品(以下简称XX)。该产品供医疗单位_____( 用途 )___________________。 2 规范性引用文件 下列文件中的条款通过本标准的引用而成为本标准的条款。凡是注日期的引用文件,其随后所有的修改单(不包括勘误的内容)或修订版均不适用于本标准,然而,鼓励根据本标准达成协议的各方研究是否可使用这些文件的最新版本。凡是不注日期的引用文件,其最新版本适用于本标准。 GB/T 191—2000 包装储运图示标本 GB 9706.1—1995 医用电器设备第一部分:安全通用要求 GB/T 14710—1993 医用电器设备环境要求及试验方法 3 结构和基本参数 3.1 结构:XXX产品由主机、控制部分、输出部分组成。
欧盟医疗器械CE认证监管模式简介 一、欧盟简介 欧洲联盟(European Union),简称欧盟(EU),是由欧洲共同体(European Communities) 发展而来,是一个集政治实体和经济实体于一身、在世界上具有重要影响的区域一体化组织。1991年12月,欧洲共同体马斯特里赫特首脑会议通过《欧洲联盟条约》,通称《马斯特里赫特条约》(简称《马约》)。1993年11月1日,《马约》正式生效,欧盟正式诞生。欧盟的宗旨是―通过建立无内部边界的空间,加强经济、社会的协调发展和建立最终实行统一货币的经济货币联盟,促进成员国经济和社会的均衡发展‖,―通过实行共同外交和安全政策,在国际舞台上弘扬联盟的个性‖。目前欧盟有27个成员国(Member State),4个自由贸易区域(European Free Trade Area)。 欧盟的主要组织机构有: 欧洲理事会(European Council) ,即首脑会议,由欧盟成员国国家元首或政府首脑及欧盟委员会主席组成。是欧盟的最高权力机构。理事会下设有总秘书处。 欧盟委员会(Commission of European Union) ,是欧盟的常设执行机构。负责实施欧盟条约和欧盟理事会做出的决定,处理日常事务,代表欧盟对外联系和进行贸易等方面的谈判。 欧洲议会(European Parliament) ,是欧洲联盟的执行监督、咨询机构,在某些领域有立法职能,并有部分预算决定权。欧洲议会可以2/3多数弹劾欧盟委员会,迫其集体辞职。 二、医疗器械的相关法规文件 目前,欧盟已颁布实施的医疗器械指令有三个,包括: 1、有源植入医疗器械指令(EC-Directive 90/385/EEC)。该指令适用于心脏起搏器、可植入的胰岛素泵等有源植入医疗器械,于1993年1月1日生效,1995年1月1日强制实施。 2、医疗器械指令(EC-Directive 93/42/EEC)。该指令适用于除90/385 EEC指令和98/79 EEC指令规定以外的一般医疗器械,于1995年1月1日生效,并于1998年6月14日强制实施。 3、体外诊断医疗器械指令(EC-Directive 98/79/EEC)。该指令适用于血细胞计数器、妊娠检测装置等体外诊断用医疗器械,于1998年12月7日生效,2003年12月7日强制实施。 上述指令是欧盟范围内统一执行的医疗器械管理法规,其法律地位相当于中国的《医疗器械监督管理条例》和日本的药事法(The Pharmaceutical Affairs Law)。 三个医疗器械指令虽然颁布的时间不同,但相互关联。医疗器械指令(EC-Directive 93/42/EEC)是在有源植入医疗器械指令(EC-Directive 90/385/EEC)的基础上制订的,二者又同为体外诊断医疗器械指令(EC-Directive 98/79/EEC)的编写基础。三个指令的格式、内容、基本要求大致相同,并针对医疗器械的不同特点而规定了特殊条款。当新颁布的指令对已有指令的基本要求进行修改时,已有指令同时进行相应修订。 医疗器械指令(EC-Directive 93/42/EEC)由23项条款和12个附录组成,其主要内容为: 1、定义和范围(Definitions,scope) 2、上市与投入使用(Placing on the market and putting into service) 该条款中规定制造商需采取所有必要的措施,确保医疗器械在依照设计的目的安装、维护和使用时不会危及患者、使用者或相关人员的安全及健康。 3、基本要求(Essential requirements) 该条款中规定医疗器械必须符合指令附录Ⅰ中的基本要求。 4、医疗器械的自由流通和特殊用途的医疗器械(Free movement,devices intended for special purposes) 该条款中规定各成员国不能对符合指令规定的临床研究用器械、定制器械和带有CE标记的医疗器械产品设置流通障碍。同时规定定制器械、参展器械和临床研究用器械在使用时可无需带有CE标记。 5、可参考的标准(Reference to standards) 6、标准与技术法规委员会(Committee on Standards and Technical Regulations) 该条款规定依据83/189/EEC号指令第五条所设立的委员会应协助欧盟委员会工作。
附件1 药品、医疗器械产品注册收费标准 一、药品注册费 国务院食品药品监督管理部门和省级食品药品监督管理部门依照法定职责,对新药临床试验申请、生产申请、仿制药申请、补充申请和再注册申请开展行政受理、现场检查/核查、技术审评等注册工作,并按标准收取有关费用。具体收费标准如下: 药品注册费标准 单位:万元 注:1.药品注册收费按一个原料药或一个制剂为一个品种计收,如再增加一种规格,则按相应类别增收20%注册费。 2.《药品注册管理办法》中属于省级食品药品监督管理部门备案或国务院食品药品监督管理部门直接备案的药品补充申请事项,不收取补充申请注册费,如此类申请经审核认为申请内容需要技术审评的,申请人应按照需要技术审评的补充申请的收费标准补交费用。 3.申请一次性进口药品的,收取药品注册费0.20万元。 4.进口药品注册收费标准在国内相应注册收费标准基础上加收国内外检查交通费、住宿费和伙食费等差额。 5.港、澳、台药品注册收费标准按进口药品注册收费标准执行。 6.药品注册加急费收费标准另行制定。 —3 —
二、医疗器械产品注册费 国务院食品药品监督管理部门和省级食品药品监督管理部门依照法定职责,对第二类、第三类医疗器械产品首次注册、变更注册、延续注册申请以及第三类高风险医疗器械临床试验申请开展行政受理、质量管理体系核查、技术审评等注册工作,并按标准收取有关费用。具体收费标准如下: 医疗器械产品注册费标准 单位:万元 注:1.医疗器械产品注册收费按《医疗器械注册管理办法》、《体外诊断试剂注册管理办法》确定的注册单元计收。 2.《医疗器械注册管理办法》、《体外诊断试剂注册管理办法》中属于备案的登记事项变更申请,不收取变更注册申请费。 3.进口医疗器械产品首次注册收费标准在境内相应注册收费标准基础上加收境内外 检查交通费、住宿费和伙食费等差额。 4. 港、澳、台医疗器械产品注册收费标准按进口医疗器械产品注册收费标准执行。 5.医疗器械产品注册加急费收费标准另行制定。 —4 —
YZB 医疗器械注册产品标准 YZB/苏(常)XXXX-200X 标准名称 标准英文名称(进口产品) 200X-XX-XX 发布200X-XX-XX 实施 X X X X (企业)发布
前言 XXX(产品名称)目前尚无国家标准和行业标准,根据《医疗器械标准管理办法》,特制定本标准,作为企业生产、监督的依据。 本标准的编写符合GB/T1.1-2000、GB/T1.2-2002和《医疗器械注册产品标准编写规范》的有关要求。 本标准的附录X是规范性附录; 本标准的附录X是资料性附录。 本标准由XXXXXXXXX(企业名称)提出。 本标准由XXXXXXXXX(企业名称)负责起草。 本标准主要起草人:XXX、XXX。 本标准首次发布时间:200X年X月。
XXXXXXXXX(标准名称) 1 范围 本标准规定了XXXXX的分类和标识、要求、试验方法、标志、使用说明书、包装、运输、储存的要求。 本标准适用于XXXXX(以下简称XXX)。该产品用于XXXXXXXXXXXXXXXXXXXXXXXX。 2 规范性引用文件 下列文件中的条款通过本标准的引用而成为本标准的条款。凡是注日期的引用文件,其随后所有的修改单(不包括勘误的内容)或修订版均不适用于本标准,然而,鼓励根据本标准达成协议的各方研究是否可使用这些文件的最新版本。凡是不注日期的引用文件,其最新版本适用于本标准。 GB XXXX-XXXX XXXXXXX YY XXXX-XXXX XXXXXXX ISO XXXXX-X:XXXXX XXXXX 3 分类和标记 3.1 分类 (产品的组成、结构、型式,结构、型式可用图表示、规格尺寸可列表表示) 3.2 标记 (为符合标准要求的产品(系列)建立一个分类、型号、产品代码) 4 要求 4.1外观 4.2尺寸 4.3 物理(或机械)性能 如强度、硬度、弹性、耐热性、耐磨性等。 4.4 使用性能 4.5 化学性能 如还原物质(易氧化物)、金属离子、酸碱度、蒸发残渣、紫外吸光度、环氧乙烷残留量等。 4.6 生物性能 如无菌、热原、溶血、刺激、致敏等(按GB/T16886.1) 4.7 安全性能 GB 9706医用电气设备通用安全要求系列标准; GB/T16886医疗器械生物学评价系列标准; YY/T口腔材料生物学评价系列标准; 及其他安全要求。 4.8 其他方面的要求 5 试验方法 5.1 外观 5.2 尺寸
精品文档 YZB 标准名称 (企业单位名称)发布
前言 XXX产品是我公司开发的新产品。目前该产品尚无国家标准、行业标准,为规范产品的技术特性,确保产品的安全有效,特制订本注册产品标准,做为生产质量控制的依据。 XXX产品注册产品标准引用了GB191《包装储运图示标志》,GBT14710《医用电气设备环境要求及试验方法》,GB9706.1《医用电气设备第一部分:安全通用要求》等标准中的内容。本标准的安全要求全面贯彻了GB9706.1—1995。并将其列入本标准附录A(规范性附录)。 本标准的附录A是规范性附录 本注册标准由天津市XXXXXXX公司提出并负责起草。 本注册标准主要起草人:XXX。 本注册标准首次发布于200X年XX月。 本注册标准由天津市XXXX(企业名称)法定代表人批准,并对所规定的内容负责。
标准名称 1 范围 本标准规定了XXX产品的结构和基本参数、要求、试验方法、检验规则、标志、包装、运输、贮存。 本标准适用于XXX产品(以下简称XX)。该产品供医疗单位_____( 用途)___________________。 2 规范性引用文件 下列文件中的条款通过本标准的引用而成为本标准的条款。凡是注日期的引用文件,其随后所有的修改单(不包括勘误的内容)或修订版均不适用于本标准,然而,鼓励根据本标准达成协议的各方研究是否可使用这些文件的最新版本。凡是不注日期的引用文件,其最新版本适用于本标准。 GB/T 191—2000 包装储运图示标本 GB 9706.1—1995 医用电器设备第一部分:安全通用要求 GB/T 14710—1993 医用电器设备环境要求及试验方法 3 结构和基本参数 3.1 结构:XXX产品由主机、控制部分、输出部分组成。 3.2 XXX产品的型号为:XX-XX-XX XX-XX-XX (对符号的解释)设计序号(产品规格)(罗马字母) (对符号的解释)产品分类(英文字母) (对符号的解释)企业名称简称(以汉字拼音字头) 3.3 XXX产品的基本参数 3.3.1 3.3.2 4 要求 4.1 XXX产品的工作条件 a)温度:5℃—40℃ b)相对湿度:不大于80% c)电源电压:AC220V±22V d)频率:50Hz±1Hz 4.2 性能指标: 4.2.1 XXX产品工作时噪声不大于60dB(A) 4.2.2 牵引力设置范围: 4.2.3 牵引治疗时间: 4.2.4 预置指示力示值与实际作用力误差: 4.2.5 预置指示时间与实际有效时间误差不大于±5% 4.3 安全
目次 目次 (1) 前言 (4) 1.范围 (4) 2.规范性引用文件 (4) 3.分类 (4) 3.1术语与定义................................................................................................................ 错误!未定义书签。 3.2管理分类 (4) 3.3命名与型号 (4) 3.4组成 (4) 4.要求 (4) 4.1产品说明要求 (4) 4.1.1可用性 (4) 4.1.2内容 (4) 4.1.3标识和标示 (5) 4.1.4功能性陈述 (6) 4.1.4.1功能概述 (6) 4.1.4.1.1远程会诊系统 (6) 4.1.4.1.2双向转诊系统............................................................................................ 错误!未定义书签。 4.1.4.1.3计费系统.................................................................................................... 错误!未定义书签。 4.1.4.1.4医疗资源共享系统.................................................................................... 错误!未定义书签。 4.1.4.1.5管理系统.................................................................................................... 错误!未定义书签。 4.1.4.2 产品的功能........................................................................................................... 错误!未定义书签。 4.1.4.3当有软件组件的选项和版本时,应指明。 (6) 4.1.4.4功能性限制 .................................................................................................... 错误!未定义书签。 4.1.4.5对未授权访问的预防措施 (6) 4.1.5可靠性陈述 (6) 4.1.6易用性陈述 (6) 4.1.7效率陈述 (7) 4.1.8维护性陈述 (7) 4.1.9可移植性陈述 (7) 4.2用户文档集要求 (7) 4.2.1完备性 (7) 4.2.2正确性 (8) 4.2.3一致性 (8) 4.2.4易理解性 (8)