21 C.F.R. § 868.5655
Portable liquid oxygen unit.
Cite as 21 C.F.R. § 868.5655 (2026)
(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).