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U.S. Department of Health and Human Services

CFR - Code of Federal Regulations Title 21

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Help | More About 21CFR
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER H--MEDICAL DEVICES
 
PART 880GENERAL HOSPITAL AND PERSONAL USE DEVICES
 

Subpart A--General Provisions
   § 880.1 - Scope.
   § 880.3 - Effective dates of requirement for premarket approval.
   § 880.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

Subpart B [Reserved]

Subpart C--General Hospital and Personal Use Monitoring Devices
   § 880.2200 - Liquid crystal forehead temperature strip.
   § 880.2400 - Bed-patient monitor.
   § 880.2420 - Electronic monitor for gravity flow infusion systems.
   § 880.2460 - Electrically powered spinal fluid pressure monitor.
   § 880.2500 - Spinal fluid manometer.
   § 880.2700 - Stand-on patient scale.
   § 880.2720 - Patient scale.
   § 880.2740 - Surgical sponge scale.
   § 880.2800 - Sterilization process indicator.
   § 880.2900 - Clinical color change thermometer.
   § 880.2910 - Clinical electronic thermometer.
   § 880.2920 - Clinical mercury thermometer.
   § 880.2930 - Apgar timer.

Subparts D-E [Reserved]

Subpart F--General Hospital and Personal Use Therapeutic Devices
   § 880.5025 - I.V. container.
   § 880.5045 - Medical recirculating air cleaner.
   § 880.5075 - Elastic bandage.
   § 880.5090 - Liquid bandage.
   § 880.5100 - AC-powered adjustable hospital bed.
   § 880.5110 - Hydraulic adjustable hospital bed.
   § 880.5120 - Manual adjustable hospital bed.
   § 880.5130 - Infant radiant warmer.
   § 880.5140 - Pediatric hospital bed.
   § 880.5150 - Nonpowered flotation therapy mattress.
   § 880.5160 - Therapeutic medical binder.
   § 880.5180 - Burn sheet.
   § 880.5200 - Intravascular catheter.
   § 880.5210 - Intravascular catheter securement device.
   § 880.5240 - Medical adhesive tape and adhesive bandage.
   § 880.5270 - Neonatal eye pad.
   § 880.5300 - Medical absorbent fiber.
   § 880.5400 - Neonatal incubator.
   § 880.5410 - Neonatal transport incubator.
   § 880.5420 - Pressure infusor for an I.V. bag.
   § 880.5430 - Nonelectrically powered fluid injector.
   § 880.5440 - Intravascular administration set.
   § 880.5445 - Intravascular Administration Set, Automated Air Removal System.
   § 880.5450 - Patient care reverse isolation chamber.
   § 880.5475 - Jet lavage.
   § 880.5500 - AC-powered patient lift.
   § 880.5510 - Non-AC-powered patient lift.
   § 880.5550 - Alternating pressure air flotation mattress.
   § 880.5560 - Temperature regulated water mattress.
   § 880.5570 - Hypodermic single lumen needle.
   § 880.5580 - Acupuncture needle.
   § 880.5630 - Nipple shield.
   § 880.5640 - Lamb feeding nipple.
   § 880.5680 - Pediatric position holder.
   § 880.5700 - Neonatal phototherapy unit.
   § 880.5725 - Infusion pump.
   § 880.5740 - Suction snakebite kit.
   § 880.5760 - Chemical cold pack snakebite kit.
   § 880.5780 - Medical support stocking.
   § 880.5820 - Therapeutic scrotal support.
   § 880.5860 - Piston syringe.
   § 880.5950 - Umbilical occlusion device.
   § 880.5960 - Lice removal kit.
   § 880.5965 - Subcutaneous, implanted, intravascular infusion port and catheter.
   § 880.5970 - Percutaneous, implanted, long-term intravascular catheter.

Subpart G--General Hospital and Personal Use Miscellaneous Devices
   § 880.6025 - Absorbent tipped applicator.
   § 880.6050 - Ice bag.
   § 880.6060 - Medical disposable bedding.
   § 880.6070 - Bed board.
   § 880.6080 - Cardiopulmonary resuscitation board.
   § 880.6085 - Hot/cold water bottle.
   § 880.6100 - Ethylene oxide gas aerator cabinet.
   § 880.6140 - Medical chair and table.
   § 880.6150 - Ultrasonic cleaner for medical instruments.
   § 880.6175 - [Reserved]
   § 880.6185 - Cast cover.
   § 880.6190 - Mattress cover for medical purposes.
   § 880.6200 - Ring cutter.
   § 880.6230 - Tongue depressor.
   § 880.6250 - Patient examination glove.
   § 880.6260 - Filtering facepiece respirator for use by the general public in public health medical emergencies.
   § 880.6265 - Examination gown.
   § 880.6280 - Medical insole.
   § 880.6300 - Implantable radiofrequency transponder system for patient identification and health information.
   § 880.6305 - Ingestible event marker.
   § 880.6310 - Medical device data system.
   § 880.6315 - Remote Medication Management System.
   § 880.6320 - AC-powered medical examination light.
   § 880.6350 - Battery-powered medical examination light.
   § 880.6375 - Patient lubricant.
   § 880.6430 - Liquid medication dispenser.
   § 880.6450 - Skin pressure protectors.
   § 880.6500 - Medical ultraviolet air purifier.
   § 880.6710 - Medical ultraviolet water purifier.
   § 880.6730 - Body waste receptacle.
   § 880.6740 - Vacuum-powered body fluid suction apparatus.
   § 880.6760 - Protective restraint.
   § 880.6775 - Powered patient transfer device.
   § 880.6785 - Manual patient transfer device.
   § 880.6800 - Washers for body waste receptacles.
   § 880.6820 - Medical disposable scissors.
   § 880.6850 - Sterilization wrap.
   § 880.6860 - Ethylene oxide gas sterilizer.
   § 880.6870 - Dry-heat sterilizer.
   § 880.6880 - Steam sterilizer.
   § 880.6885 - Liquid chemical sterilants/high level disinfectants.
   § 880.6890 - General purpose disinfectants.
   § 880.6900 - Hand-carried stretcher.
   § 880.6910 - Wheeled stretcher.
   § 880.6920 - Syringe needle introducer.
   § 880.6960 - Irrigating syringe.
   § 880.6970 - Liquid crystal vein locator.
   § 880.6980 - Vein stabilizer.
   § 880.6990 - Infusion stand.
   § 880.6991 - Medical washer.
   § 880.6992 - Medical washer-disinfector.

Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 371.
Source: 45 FR 69682, Oct. 21, 1980, unless otherwise noted.

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