21 CFR 868.5655 — Unit, Liquid-Oxygen, Portable
Anesthesiology (AN) · Part 868 Subpart F—Therapeutic Devices · § 868.5655
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.
Classification Rationale
Class II (performance standards).
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| BYJ | Unit, Liquid-Oxygen, Portable | 2 | 55 | 3rd Party |
| OGL | Oxygen Administration Kit | 2 | 0 |