OGL · Oxygen Administration Kit
Anesthesiology · 21 CFR 868.5655 · Class 2
Overview
| Product Code | OGL |
|---|---|
| Device Name | Oxygen Administration Kit |
| Regulation | 21 CFR 868.5655 |
| Device Class | Class 2 |
| Review Panel | Anesthesiology |
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).
Recent Cleared Devices (0 of 0)
No cleared devices on record.
