Regulations last checked for updates: May 01, 2025

Title 21 - Food and Drugs last revised: Apr 28, 2025
§ 868.5655 - Portable liquid oxygen unit.

(a) Identification. A portable liquid oxygen unit is a portable, thermally insulated container of liquid oxygen that is intended to supplement gases to be inhaled by a patient, is sometimes accompanied by tubing and an oxygen mask. An empty portable liquid oxygen unit is a device, while the oxygen contained therein is a drug.

(b) Classification. Class II (performance standards).

authority: 21 U.S.C. 351,360,360c,360e,360j,360
source: 47 FR 31142, July 16, 1982, unless otherwise noted.
cite as: 21 CFR 868.5655