21 C.F.R. § 868.5655 Portable liquid oxygen unit.
Title 21 - Food and Drugs
(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).
Title 21: Food and Drugs
PART 868—ANESTHESIOLOGY DEVICES
Subpart F—Therapeutic Devices
§ 868.5655 Portable liquid oxygen unit.
