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e-CFR data is current as of February 23, 2021 |
Title 21 → Chapter I → Subchapter H → Part 868 → Subpart F → §868.5655 |
Title 21: Food and Drugs
PART 868—ANESTHESIOLOGY DEVICES
Subpart F—Therapeutic Devices
§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).