Part 880 - GENERAL HOSPITAL AND PERSONAL USE DEVICES  


Subparts D–E [Reserved]
Subparts D-E [Reserved]
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.
§ 880.2750 Image processing device for estimation of external blood loss.
§ 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.
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 medical crib.
§ 880.5145 Medical bassinet.
§ 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.
§ 880.6210 Sharps needle destruction device.
§ 880.6230 Tongue depressor.
§ 880.6250 Non-powdered 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.
§ 880.6600 Ultraviolet (UV) radiation chamber disinfection device.
§ 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.

EditorNote

, Nomenclature changes to part 880 appear at 73 FR 35341, June 23, 2008.