Title 21

PART 868 SUBPART F

Subpart F - Therapeutic Devices

• 21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.
• 47 FR 31142, July 16, 1982, unless otherwise noted.

21:8.0.1.1.21.5.1.1	SECTION 868.5090	868.5090 Emergency airway needle.
21:8.0.1.1.21.5.1.2	SECTION 868.5100	868.5100 Nasopharyngeal airway.
21:8.0.1.1.21.5.1.3	SECTION 868.5105	868.5105 External negative pressure airway aid.
21:8.0.1.1.21.5.1.4	SECTION 868.5110	868.5110 Oropharyngeal airway.
21:8.0.1.1.21.5.1.5	SECTION 868.5115	868.5115 Device to relieve acute upper airway obstruction.
21:8.0.1.1.21.5.1.6	SECTION 868.5120	868.5120 Anesthesia conduction catheter.
21:8.0.1.1.21.5.1.7	SECTION 868.5130	868.5130 Anesthesia conduction filter.
21:8.0.1.1.21.5.1.8	SECTION 868.5140	868.5140 Anesthesia conduction kit.
21:8.0.1.1.21.5.1.9	SECTION 868.5150	868.5150 Anesthesia conduction needle.
21:8.0.1.1.21.5.1.10	SECTION 868.5160	868.5160 Gas machine for anesthesia or analgesia.
21:8.0.1.1.21.5.1.11	SECTION 868.5165	868.5165 Nitric oxide administration apparatus.
21:8.0.1.1.21.5.1.12	SECTION 868.5170	868.5170 Laryngotracheal topical anesthesia applicator.
21:8.0.1.1.21.5.1.13	SECTION 868.5180	868.5180 Rocking bed.
21:8.0.1.1.21.5.1.14	SECTION 868.5220	868.5220 Blow bottle.
21:8.0.1.1.21.5.1.15	SECTION 868.5240	868.5240 Anesthesia breathing circuit.
21:8.0.1.1.21.5.1.16	SECTION 868.5250	868.5250 Breathing circuit circulator.
21:8.0.1.1.21.5.1.17	SECTION 868.5260	868.5260 Breathing circuit bacterial filter.
21:8.0.1.1.21.5.1.18	SECTION 868.5270	868.5270 Breathing system heater.
21:8.0.1.1.21.5.1.19	SECTION 868.5273	868.5273 Positive airway pressure delivery system.
21:8.0.1.1.21.5.1.20	SECTION 868.5280	868.5280 Breathing tube support.
21:8.0.1.1.21.5.1.21	SECTION 868.5300	868.5300 Carbon dioxide absorbent.
21:8.0.1.1.21.5.1.22	SECTION 868.5310	868.5310 Carbon dioxide absorber.
21:8.0.1.1.21.5.1.23	SECTION 868.5320	868.5320 Reservoir bag.
21:8.0.1.1.21.5.1.24	SECTION 868.5330	868.5330 Breathing gas mixer.
21:8.0.1.1.21.5.1.25	SECTION 868.5340	868.5340 Nasal oxygen cannula.
21:8.0.1.1.21.5.1.26	SECTION 868.5350	868.5350 Nasal oxygen catheter.
21:8.0.1.1.21.5.1.27	SECTION 868.5365	868.5365 Posture chair for cardiac or pulmonary treatment.
21:8.0.1.1.21.5.1.28	SECTION 868.5375	868.5375 Heat and moisture condenser (artificial nose).
21:8.0.1.1.21.5.1.29	SECTION 868.5400	868.5400 Electroanesthesia apparatus.
21:8.0.1.1.21.5.1.30	SECTION 868.5420	868.5420 Ether hook.
21:8.0.1.1.21.5.1.31	SECTION 868.5430	868.5430 Gas-scavenging apparatus.
21:8.0.1.1.21.5.1.32	SECTION 868.5440	868.5440 Portable oxygen generator.
21:8.0.1.1.21.5.1.33	SECTION 868.5450	868.5450 Respiratory gas humidifier.
21:8.0.1.1.21.5.1.34	SECTION 868.5454	868.5454 High flow humidified oxygen delivery device.
21:8.0.1.1.21.5.1.35	SECTION 868.5460	868.5460 Therapeutic humidifier for home use.
21:8.0.1.1.21.5.1.36	SECTION 868.5470	868.5470 Hyperbaric chamber.
21:8.0.1.1.21.5.1.37	SECTION 868.5530	868.5530 Flexible laryngoscope.
21:8.0.1.1.21.5.1.38	SECTION 868.5540	868.5540 Rigid laryngoscope.
21:8.0.1.1.21.5.1.39	SECTION 868.5550	868.5550 Anesthetic gas mask.
21:8.0.1.1.21.5.1.40	SECTION 868.5560	868.5560 Gas mask head strap.
21:8.0.1.1.21.5.1.41	SECTION 868.5570	868.5570 Nonrebreathing mask.
21:8.0.1.1.21.5.1.42	SECTION 868.5580	868.5580 Oxygen mask.
21:8.0.1.1.21.5.1.43	SECTION 868.5590	868.5590 Scavenging mask.
21:8.0.1.1.21.5.1.44	SECTION 868.5600	868.5600 Venturi mask.
21:8.0.1.1.21.5.1.45	SECTION 868.5620	868.5620 Breathing mouthpiece.
21:8.0.1.1.21.5.1.46	SECTION 868.5630	868.5630 Nebulizer.
21:8.0.1.1.21.5.1.47	SECTION 868.5640	868.5640 Medicinal nonventilatory nebulizer (atomizer).
21:8.0.1.1.21.5.1.48	SECTION 868.5650	868.5650 Esophageal obturator.
21:8.0.1.1.21.5.1.49	SECTION 868.5655	868.5655 Portable liquid oxygen unit.
21:8.0.1.1.21.5.1.50	SECTION 868.5665	868.5665 Powered percussor.
21:8.0.1.1.21.5.1.51	SECTION 868.5675	868.5675 Rebreathing device.
21:8.0.1.1.21.5.1.52	SECTION 868.5690	868.5690 Incentive spirometer.
21:8.0.1.1.21.5.1.53	SECTION 868.5700	868.5700 Nonpowered oxygen tent.
21:8.0.1.1.21.5.1.54	SECTION 868.5710	868.5710 Electrically powered oxygen tent.
21:8.0.1.1.21.5.1.55	SECTION 868.5720	868.5720 Bronchial tube.
21:8.0.1.1.21.5.1.56	SECTION 868.5730	868.5730 Tracheal tube.
21:8.0.1.1.21.5.1.57	SECTION 868.5740	868.5740 Tracheal/bronchial differential ventilation tube.
21:8.0.1.1.21.5.1.58	SECTION 868.5750	868.5750 Inflatable tracheal tube cuff.
21:8.0.1.1.21.5.1.59	SECTION 868.5760	868.5760 Cuff spreader.
21:8.0.1.1.21.5.1.60	SECTION 868.5770	868.5770 Tracheal tube fixation device.
21:8.0.1.1.21.5.1.61	SECTION 868.5780	868.5780 Tube introduction forceps.
21:8.0.1.1.21.5.1.62	SECTION 868.5790	868.5790 Tracheal tube stylet.
21:8.0.1.1.21.5.1.63	SECTION 868.5795	868.5795 Tracheal tube cleaning brush.
21:8.0.1.1.21.5.1.64	SECTION 868.5800	868.5800 Tracheostomy tube and tube cuff.
21:8.0.1.1.21.5.1.65	SECTION 868.5810	868.5810 Airway connector.
21:8.0.1.1.21.5.1.66	SECTION 868.5820	868.5820 Dental protector.
21:8.0.1.1.21.5.1.67	SECTION 868.5830	868.5830 Autotransfusion apparatus.
21:8.0.1.1.21.5.1.68	SECTION 868.5860	868.5860 Pressure tubing and accessories.
21:8.0.1.1.21.5.1.69	SECTION 868.5870	868.5870 Nonrebreathing valve.
21:8.0.1.1.21.5.1.70	SECTION 868.5880	868.5880 Anesthetic vaporizer.
21:8.0.1.1.21.5.1.71	SECTION 868.5895	868.5895 Continuous ventilator.
21:8.0.1.1.21.5.1.72	SECTION 868.5905	868.5905 Noncontinuous ventilator (IPPB).
21:8.0.1.1.21.5.1.73	SECTION 868.5915	868.5915 Manual emergency ventilator.
21:8.0.1.1.21.5.1.74	SECTION 868.5925	868.5925 Powered emergency ventilator.
21:8.0.1.1.21.5.1.75	SECTION 868.5935	868.5935 External negative pressure ventilator.
21:8.0.1.1.21.5.1.76	SECTION 868.5955	868.5955 Intermittent mandatory ventilation attachment.
21:8.0.1.1.21.5.1.77	SECTION 868.5965	868.5965 Positive end expiratory pressure breathing attachment.
21:8.0.1.1.21.5.1.78	SECTION 868.5975	868.5975 Ventilator tubing.
21:8.0.1.1.21.5.1.79	SECTION 868.5995	868.5995 Tee drain (water trap).

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