Food and Drug Administration, HHS § 868.5650 § 868.5580 Oxygen mask. been established of the requirement for premarket approval. See § 868.3. (a) Identification. An oxygen mask is a device placed over a patient’s nose, [47 FR 31142, July 16, 1982, as amended at 52 mouth, or tracheostomy to administer FR 17735, May 11, 1987] oxygen or aerosols. (b) Classification. Class I (general con- § 868.5620 Breathing mouthpiece. trols). The device is exempt from the (a) Identification. A breathing mouth- premarket notification procedures in piece is a rigid device that is inserted subpart E of part 807 of this chapter into a patient’s mouth and that con- subject to the limitations in § 868.9. nects with diagnostic or therapeutic respiratory devices. [47 FR 31142, July 16, 1982, as amended at 61 (b) Classification. Class I (general con- FR 1120, Jan. 16, 1996; 66 FR 38795, July 25, trols). The device is exempt from the 2001] premarket notification procedures in § 868.5590 Scavenging mask. subpart E of part 807 of this chapter subject to § 868.9. (a) Identification. A scavenging mask is a device positioned over a patient’s [47 FR 31142, July 16, 1982, as amended at 65 nose to deliver anesthetic or analgesic FR 2313, Jan. 14, 2000] gases to the upper airway and to re- § 868.5630 Nebulizer. move excess and exhaled gas. It is usu- ally used during dentistry. (a) Identification. A nebulizer is a de- (b) Classification. Class I (general con- vice intended to spray liquids in aer- trols). The device is exempt from the osol form into gases that are delivered premarket notification procedures in directly to the patient for breathing. subpart E of part 807 of this chapter Heated, ultrasonic, gas, venturi, and subject to the limitations in § 868.9. refillable nebulizers are included in this generic type of device. [47 FR 31142, July 16, 1982, as amended at 61 (b) Classification. Class II (perform- FR 1120, Jan. 16, 1996; 66 FR 38795, July 25, ance standards). 2001] § 868.5640 Medicinal nonventilatory § 868.5600 Venturi mask. nebulizer (atomizer). (a) Identification. A venturi mask is a (a) Identification. A medicinal non- device containing an air-oxygen mixing ventilatory nebulizer (atomizer) is a mechanism that dilutes 100 percent ox- device that is intended to spray liquid ygen to a predetermined concentration medication in aerosol form into the air and delivers the mixed gases to a pa- that a patient will breathe. tient. (b) Classification. Class I (general con- (b) Classification. Class I (general con- trols). The device is exempt from the trols). The device is exempt from the premarket notification procedures in premarket notification procedures in subpart E of part 807 of this chapter subpart E of part 807 of this chapter subject to § 868.9. subject to the limitations in § 868.9. [47 FR 31142, July 16, 1982, as amended at 65 [47 FR 31142, July 16, 1982, as amended at 61 FR 2313, Jan. 14, 2000] FR 1120, Jan. 16, 1996; 66 FR 38795, July 25, 2001] § 868.5650 Esophageal obturator. (a) Identification. An esophageal obtu- § 868.5610 Membrane lung for long- rator is a device inserted through a pa- term pulmonary support. tient’s mouth to aid ventilation of the (a) Identification. A membrane lung patient during emergency resuscitation for long-term pulmonary support is a by occluding (blocking) the esophagus, device used to provide to a patient thereby permitting positive pressure extracorporeal blood oxygenation for ventilation through the trachea. The longer than 24 hours. device consists of a closed-end (b) Classification. Class III (premarket semirigid esophageal tube that is at- approval). tached to a face mask. (c) Date PMA or notice of completion of (b) Classification. Class II (perform- a PDP is required. No effective date has ance standards). 341 VerDate Mar<15>2010 18:43 May 19, 2014 Jkt 232077 PO 00000 Frm 00351 Fmt 8010 Sfmt 8010 Q:\21\21V8.TXT ofr150 PsN: PC150.