Source: https://www.law.cornell.edu/cfr/text/21/part-880/subpart-G
Timestamp: 2016-07-25 22:16:51
Document Index: 621433427

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21 CFR Part 880, Subpart G - General Hospital and Personal Use Miscellaneous Devices | US Law | LII / Legal Information Institute
CFR › Title 21 › Chapter I › Subchapter H › Part 880 › Subpart G 21 CFR Part 880, Subpart G - General Hospital and Personal Use Miscellaneous Devices
There is 1 Update appearing in the Federal Register for 21 CFR Part 880. View below or at eCFR (GPOAccess)
§ 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.
Title 21 published on 2015-04-01.The following are only the Rules published in the Federal Register after the published date of Title 21.For a complete list of all Rules, Proposed Rules, and Notices view the Rulemaking tab.2015-11-20; vol. 80 # 224 - Friday, November 20, 201580 FR 72587 - Medical Devices; General Hospital and Personal Use Devices; Classification of the Ultraviolet Radiation Chamber Disinfection Device
typeregulations.gov FR Doc.2015-29660 RIN Docket No.FDA-2015-N-3838 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final order. This order is effective November 20, 2015. The classification was applicable on December 20, 2011. 21 CFR Part 880 SummaryThe Food and Drug Administration (FDA or the Agency) is classifying the ultraviolet (UV) radiation chamber disinfection device into class II (special controls). The special controls that will apply to the device are identified in this order and will be part of the codified language for the UV radiation chamber disinfection device classification. The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device.
Title 21 published on 2015-04-01The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 21 CFR Part 880 after this date.2015-11-20; vol. 80 # 224 - Friday, November 20, 201580 FR 72587 - Medical Devices; General Hospital and Personal Use Devices; Classification of the Ultraviolet Radiation Chamber Disinfection Device
2015-10-08; vol. 80 # 195 - Thursday, October 8, 201580 FR 60809 - General Hospital and Personal Use Devices: Renaming of Pediatric Hospital Bed Classification and Designation of Special Controls for Pediatric Medical Crib; Classification of Medical Bassinet
typeregulations.gov FR Doc.2015-25627 RIN Docket No.FDA-2015-N-0701 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Proposed rule. Submit either electronic or written comments by December 7, 2015. See section VII of this document for the proposed effective date of a final rule based on this proposed rule. 21 CFR Part 880 SummaryThe Food and Drug Administration (FDA) is proposing to rename pediatric hospital beds as pediatric medical cribs and establish special controls for these devices. FDA is also proposing to establish a separate classification regulation for medical bassinets, previously under the pediatric hospital bed classification regulation, as a class II (special controls) device. The proposed regulation for both pediatric medical cribs and medical bassinets would also include the Consumer Product Safety Commission&apos;s (CPSC) mattress flammability standards for the mattresses intended for use with these devices. In addition, this proposed rule would require prescription use of pediatric medical cribs and bassinets.