General Hospital

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Code	Device name	Class	21 CFR	510(k) (3y)
BRT	Restraint, Patient, Conductive	Class 1	21 CFR 880.6760
BRZ	Set, Blood Transfusion	Class 2	21 CFR 880.5440	30
BWJ	Locator, Acupuncture Point	Class 2	21 CFR 880.5580	3
BYY	Tube, Aspirating, Flexible, Connecting	Class 2	21 CFR 880.6740	24
BYZ	Trap, Sterile Specimen	Class 2	21 CFR 880.6740	9
CAK	Microfilter, Blood Transfusion	Class 2	21 CFR 880.5440	36
CAR	Monitor, Spinal-Fluid Pressure, Electrically Powered	Class 2	21 CFR 880.2460	3
CBC	Bottle, Collection And Trap, Breathing System (Uncalibrated)	Class 2	21 CFR 880.6740	3
CBD	Bottle, Collection, Breathing System (Calibrated)	Class 2	21 CFR 880.6740	3
DWL	Stocking, Medical Support (To Prevent Pooling Of Blood In Legs)	Class 2	21 CFR 880.5780	64
FLE	Sterilizer, Steam	Class 2	21 CFR 880.6880	185
FLF	Sterilizer, Ethylene-Oxide Gas	Class 2	21 CFR 880.6860	26
FLG	Cleaner, Ultrasonic, Medical Instrument	Class 1	21 CFR 880.6150	19
FLH	Washer Of Body Waste Receptacles	Class 1	21 CFR 880.6800
FLI	Cabinet, Ethylene-Oxide Gas Aerator	Class 2	21 CFR 880.6100	8
FLK	Thermometer, Clinical Mercury	Class 2	21 CFR 880.2920	33
FLL	Continuous Measurement Thermometer	Class 2	21 CFR 880.2910	798
FLN	Monitor, Electric For Gravity Flow Infusion Systems	Class 2	21 CFR 880.2420	39
FMA	Depressor, Tongue, Non-Surgical	Class 1	21 CFR 880.6230	5
FMC	Patient Examination Glove	Class 1	21 CFR 880.6250	34
FME	Gown, Examination	Class 1	21 CFR 880.6265	5
FMF	Syringe, Piston	Class 2	21 CFR 880.5860	752
FMG	Stopcock, I.V. Set	Class 2	21 CFR 880.5440	89
FMI	Needle, Hypodermic, Single Lumen	Class 2	21 CFR 880.5570	693
FMJ	Manometer, Spinal-Fluid	Class 2	21 CFR 880.2500	6
FML	Chair, Blood Donor	Class 1	21 CFR 880.6140	2
FMP	Protector, Skin Pressure	Class 1	21 CFR 880.6450	23
FMQ	Restraint, Protective	Class 1	21 CFR 880.6760	134
FMR	Device, Transfer, Patient, Manual	Class 1	21 CFR 880.6785	5
FMS	Bed, Pediatric Open Hospital	Class 2	21 CFR 880.5140	27
FMT	Warmer, Infant Radiant	Class 2	21 CFR 880.5130	92
FMW	Cover, Mattress (Medical Purposes)	Class 1	21 CFR 880.6190	14
FMZ	Incubator, Neonatal	Class 2	21 CFR 880.5400	86
FNG	Lift, Patient, Ac-Powered	Class 2	21 CFR 880.5500	21
FNJ	Bed, Manual	Class 1	21 CFR 880.5120	39
FNK	Bed, Hydraulic, Adjustable Hospital	Class 1	21 CFR 880.5110	1
FNL	Bed, Ac-Powered Adjustable Hospital	Class 2	21 CFR 880.5100	70
FNM	Mattress, Air Flotation, Alternating Pressure	Class 2	21 CFR 880.5550	102
FNN	Nipple, Lambs Feeding	Class 1	21 CFR 880.5640
FNP	Urinal	Class 1	21 CFR 880.6730	1
FNS	Ring Cutter	Class 1	21 CFR 880.6200
FNY	Basin, Emesis	Class 1	21 CFR 880.6730	9
FOA	Board, Cardiopulmonary	Class 1	21 CFR 880.6080	3
FOB	Bedpan	Class 1	21 CFR 880.6730	5
FOD	Device, Occlusion, Umbilical	Class 1	21 CFR 880.5950
FOH	Mattress, Water, Temperature Regulated	Class 1	21 CFR 880.5560	6
FOK	Pad, Neonatal Eye	Class 1	21 CFR 880.5270	5
FOS	Catheter, Umbilical Artery	Class 2	21 CFR 880.5200	34
FOX	Stand, Infusion	Class 1	21 CFR 880.6990	36
FOZ	Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days	Class 2	21 CFR 880.5200	507
FPA	Set, Administration, Intravascular	Class 2	21 CFR 880.5440	1174
FPB	Filter, Infusion Line	Class 2	21 CFR 880.5440	98
FPF	Bottle, Hot/Cold Water	Class 1	21 CFR 880.6085	1
FPK	Tubing, Fluid Delivery	Class 2	21 CFR 880.5440	64
FPL	Incubator, Neonatal Transport	Class 2	21 CFR 880.5410	25
FPO	Stretcher, Wheeled	Class 2	21 CFR 880.6910	50
FPP	Stretcher, Hand-Carried	Class 1	21 CFR 880.6900	39
FPS	Board, Bed	Class 1	21 CFR 880.6070	1
FPX	Strip, Adhesive, Closure, Skin	Class 1	21 CFR 880.5240	35
FPY	Sheet, Burn	Class 1	21 CFR 880.5180	17
FQA	Scale, Surgical Sponge	Class 1	21 CFR 880.2740	1
FQH	Lavage, Jet	Class 2	21 CFR 880.5475	53
FQJ	Support, Scrotal, Therapeutic	Class 1	21 CFR 880.5820
FQK	Binder, Perineal	Class 1	21 CFR 880.5160
FQL	Stocking, Medical Support (For General Medical Purposes)	Class 1	21 CFR 880.5780	6
FQM	Bandage, Elastic	Class 1	21 CFR 880.5075	42
FQZ	Thermometer, Clinical Color Change	Class 1	21 CFR 880.2900	14
FRA	Purifier, Air, Ultraviolet, Medical	Class 2	21 CFR 880.6500	36
FRC	Indicator, Biological Sterilization Process	Class 2	21 CFR 880.2800	206
FRF	Cleaner, Air, Medical Recirculating	Class 2	21 CFR 880.5045	53
FRG	Wrap, Sterilization	Class 2	21 CFR 880.6850	323
FRI	Scale, Stand-On, Patient	Class 1	21 CFR 880.2700	3
FRJ	Chair, Geriatric	Class 1	21 CFR 880.6140
FRK	Chair, Examination And Treatment	Class 1	21 CFR 880.6140	4
FRL	Fiber, Medical, Absorbent	Class 1	21 CFR 880.5300	19
FRN	Pump, Infusion	Class 2	21 CFR 880.5725	849
FRP	Holder, Infant Position	Class 1	21 CFR 880.5680	14
FRR	Chamber, Reverse Isolation, Patient Care	Class 2	21 CFR 880.5450	1
FRW	Scale, Patient	Class 1	21 CFR 880.2720	48
FRZ	Device, Patient Transfer, Powered	Class 2	21 CFR 880.6775	5
FSA	Lift, Patient, Non-Ac-Powered	Class 1	21 CFR 880.5510	13
FSD	Binder, Abdominal	Class 1	21 CFR 880.5160	5
GAG	Stapler, Surgical	Class 2	21 CFR 878.4740	43
GAZ	Tubing, Noninvasive	Class 2	21 CFR 880.6740	27
GCX	Apparatus, Suction, Operating-Room, Wall Vacuum Powered	Class 2	21 CFR 880.6740	87
HEF	Binder, Breast	Class 1	21 CFR 880.5160
HFS	Shield, Nipple	Class 1	21 CFR 880.5630	12
IKY	Mattress, Flotation Therapy, Non-Powered	Class 1	21 CFR 880.5150	8
JOJ	Indicator, Physical/Chemical Sterilization Process	Class 2	21 CFR 880.2800	264
JOK	Scissors, Medical, Disposable	Class 1	21 CFR 880.6820	7
JOL	Catheter And Tip, Suction	Class 2	21 CFR 880.6740	84
KCT	Sterilization Wrap Containers, Trays, Cassettes & Other Accessories	Class 2	21 CFR 880.6850	280
KDP	Regulator, Vacuum	Class 2	21 CFR 880.6740	21
KDQ	Bottle, Collection, Vacuum	Class 2	21 CFR 880.6740	48
KGX	Tape And Bandage, Adhesive	Class 1	21 CFR 880.5240	187
KIA	Cover, Cast	Class 1	21 CFR 880.6185	1
KME	Bedding, Disposable, Medical	Class 1	21 CFR 880.6060	65
KMF	Bandage, Liquid	Class 1	21 CFR 880.5090	222
KMG	Purifier, Water, Ultraviolet, Medical	Class 2	21 CFR 880.6710	9
KMH	Sterilizer, Dry Heat	Class 2	21 CFR 880.6870	10
KMI	Monitor, Bed Patient	Class 1	21 CFR 880.2400	31
KMJ	Lubricant, Patient	Class 1	21 CFR 880.6375	49
KMK	Device, Intravascular Catheter Securement	Class 1	21 CFR 880.5210	64
KMN	Chair And Table, Medical	Class 1	21 CFR 880.6140	3
KMO	Binder, Elastic	Class 1	21 CFR 880.5160	5
KPD	Strip, Temperature, Forehead, Liquid Crystal	Class 2	21 CFR 880.2200	21
KPE	Container, I.V.	Class 2	21 CFR 880.5025	117
KXF	Applicator, Absorbent Tipped, Non-Sterile	Class 1	21 CFR 880.6025	21
KXG	Applicator, Absorbent Tipped, Sterile	Class 1	21 CFR 880.6025	1
KYP	Snake Bite Suction Kit	Class 1	21 CFR 880.5740	4
KYQ	Kit, Chemical Snake-Bite	Class 3	21 CFR 880.5760
KYR	Bag, Ice	Class 1	21 CFR 880.6050	4
KYS	Insoles, Medical	Class 1	21 CFR 880.6280	1
KYT	Light, Examination, Medical, Battery Powered	Class 1	21 CFR 880.6350	6
KYW	Container, Liquid Medication, Graduated	Class 1	21 CFR 880.6430	2
KYX	Dispenser, Liquid Medication	Class 1	21 CFR 880.6430	11
KYZ	Syringe, Irrigating (Non Dental)	Class 1	21 CFR 880.6960	41
KZA	Device, Vein Location, Liquid Crystal	Class 1	21 CFR 880.6970	6
KZD	Infusor, Pressure, For I.V. Bags	Class 1	21 CFR 880.5420	35
KZE	Injector, Fluid, Non-Electrically Powered	Class 2	21 CFR 880.5430	53
KZF	Device, Medical Examination, Ac Powered	Class 1	21 CFR 880.6320	37
KZH	Introducer, Syringe Needle	Class 2	21 CFR 880.6920	47
LBI	Unit, Neonatal Phototherapy	Class 2	21 CFR 880.5700	71
LBJ	Device, Vein Stabilization	Class 1	21 CFR 880.6980
LDR	Controller, Infusion, Intravascular, Electronic	Class 2	21 CFR 880.5725	60
LDS	Device, Pasteurization, Hot Water	Class 2	21 CFR 880.6991	11
LFE	Solution, Cold Sterilizing	Class 2	21 CFR 880.6885	1
LGM	Chamber, Patient Isolation	Class 2	21 CFR 880.5450	12
LGN	Chamber, Patient Transport Isolation	Class 2	21 CFR 880.5450	2
LGZ	Warmer, Thermal, Infusion Fluid	Class 2	21 CFR 880.5725	75
LHB	Timer, Apgar	Class 1	21 CFR 880.2930	2
LHF	Warmer, Microwave, Infusion Fluid	Class 2	21 CFR 880.5725	2
LHI	Set, I.V. Fluid Transfer	Class 2	21 CFR 880.5440	206
LJL	Detectors And Removers, Lice, (Including Combs)	Class 1	21 CFR 880.5960	11
LJS	Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days	Class 2	21 CFR 880.5970	302
LJT	Port & Catheter, Implanted, Subcutaneous, Intravascular	Class 2	21 CFR 880.5965	288
LLD	Port & Catheter, Implanted, Subcutaneous, Intraperitoneal	Class 2	21 CFR 880.5965	4
LLI	Bed, Therapeutic, Ac-Powered, Adjustable Home-Use	Class 2	21 CFR 880.5100	2
LLK	Legging, Compression, Non-Inflatable	Class 2	21 CFR 880.5780	4
LRJ	Disinfectant, Medical Devices	Class 1	21 CFR 880.6890	73
LRS	I.V. Start Kit	Class 2	21 CFR 880.5200	30
LRT	Indicator, Sterilization	Class 2	21 CFR 880.2800	5
LWH	Counter, Sponge, Surgical	Class 1	21 CFR 880.2740	15
LYY	Latex Patient Examination Glove	Class 1	21 CFR 880.6250	1954
LYZ	Vinyl Patient Examination Glove	Class 1	21 CFR 880.6250	799
LZA	Polymer Patient Examination Glove	Class 1	21 CFR 880.6250	1176
LZB	Finger Cot	Class 1	21 CFR 880.6250	5
LZC	Medical Glove, Specialty	Class 1	21 CFR 880.6250	79
LZF	Pump, Infusion, Analytical Sampling	Class 2	21 CFR 880.5725	7
LZG	Pump, Infusion, Insulin	Class 2	21 CFR 880.5725	84
LZH	Pump, Infusion, Enteral	Class 2	21 CFR 880.5725	34
MCY	Wound Dressing Kit	Class 2	21 CFR 880.5075	24
MDR	Binder, Medical, Therapeutic	Class 1	21 CFR 880.5160
MDZ	Cleaners, Medical Devices	Class 2	21 CFR 880.6992	2
MEA	Pump, Infusion, Pca	Class 2	21 CFR 880.5725	31
MEB	Pump, Infusion, Elastomeric	Class 2	21 CFR 880.5725	88
MEC	Disinfector, Medical Devices	Class 2	21 CFR 880.6992	2
MED	Sterilant, Medical Devices	Class 2	21 CFR 880.6885	64
MEG	Syringe, Antistick	Class 2	21 CFR 880.5860	162
MHC	Needle, Interosseous	Class 2	21 CFR 880.5570	2
MHD	Pump, Infusion, Gallstone Dissolution	Class 2	21 CFR 880.5725	1
MHW	Dressing, Compression	Class 1	21 CFR 880.5075	2
MJF	Check Valve, Retrograde Flow (In-Line)	Class 2	21 CFR 880.5440	1
MKB	Device, Germicidal, Ultraviolet	Class 2	21 CFR 880.6500
MLR	Sterilizer, Chemical	Class 2	21 CFR 880.6860	47
MMK	Container, Sharps	Class 2	21 CFR 880.5570	114
MMS	Lubricant, Vaginal, Patient	Class 1	21 CFR 880.6375
MQX	Needle, Acupuncture, Single Use	Class 2	21 CFR 880.5580	91
MRB	Indicator, Biological, Liquid Chemical Sterilization Process	Class 2	21 CFR 880.2800	4
MRH	Pump, Infusion, Ophthalmic	Class 2	21 CFR 880.5725	20
MRL	Scale, Sponge, Surgical, Electrically-Powered	Class 1	21 CFR 880.2740	1
MRZ	Accessories, Pump, Infusion	Class 2	21 CFR 880.5725	48
MTC	Indicator, Chemical, Enzymatic, Sterilization Process	Class 2	21 CFR 880.2800	2
MTV	Sharps Needle Destruction Device	Class 2	21 CFR 880.6210	1
MZM	Fibrin Sealant Preparation Device	Class 2	21 CFR 880.5860
MZR	Topical Approximation System	Class 1	21 CFR 880.5240
NEC	Bandage, Liquid, Skin Protectant	Class 1	21 CFR 880.5090	3
NEP	System/Device, Pharmacy Compounding	Class 2	21 CFR 880.5440
NGT	Saline, Vascular Access Flush	Class 2	21 CFR 880.5200	40
NKK	Needle, Hypodermic, Single Lumen, Reprocessed	Class 2	21 CFR 880.5570
NKN	Syringe, Piston, Reprocessed	Class 2	21 CFR 880.5860
NRV	Implantable Radio Frequency Transponder System	Class 2	21 CFR 880.6300	1
NRW	Stimulator, Intramuscular, Automatic	Class 2	21 CFR 880.5580	1
NSC	Injector, Pen	Class 2	21 CFR 880.5860	1
NTC	Nursing Pad, Hydrogel	Class 1	21 CFR 880.5630	1
NTX	Nursing Pad, Polyurethane Pad With Starch Copolymer, Glycerin, And Sur	Class 1	21 CFR 880.5630	1
NUP	Cream, Nasal, Topical, Mechanical Allergen Particle Barrier	Class 2	21 CFR 880.5045	8
NXH	Nursing Pad, Cohesive Gel	Class 1	21 CFR 880.5630	1
NZD	Stretcher, Patient Restraint	Class 1	21 CFR 880.6900	1
NZG	Bassinet, Hospital	Class 2	21 CFR 880.5145
NZH	Medication Management System, Remote	Class 2	21 CFR 880.6315	2
NZJ	Respirator, N95, For Use By The General Public In Public Health Medica	Class 2	21 CFR 880.6260	2
NZW	Heparin, Vascular Access Flush	Class 2	21 CFR 880.5200	7
NZX	Water, Vascular Access Flush	Class 2	21 CFR 880.5200
OBK	Port, Protector/Cushion	Class 2	21 CFR 880.5965	1
OCI	Indicator, Physical/Chemical, Storage Temperature	Class 2	21 CFR 880.2800	1
ODI	Administration Set Docking Station	Class 2	21 CFR 880.5440	1
ODY	Tunneled Catheter Remover	Class 2	21 CFR 880.5970	2
OGQ	Ear Irrigation Kit	Class 1	21 CFR 880.6960
OHY	Pill Crusher/Cutter	Class 1	21 CFR 880.6430