Product code
QAV: High flow/high velocity humidified oxygen delivery device
FDA product code · Class II · Anesthesiology
Key facts
| Product code | QAV |
|---|---|
| Device | High flow/high velocity humidified oxygen delivery device |
| Device class | Class II |
| Regulation number | 868.5454 |
| Review panel | Anesthesiology |
| Medical specialty | Anesthesiology |
| Submission type | 510(k) |
| GMP exempt | No |
| Implanted device | No |
| Life-sustaining or life-supporting | No |
| Definition | Intended to deliver high flow and/or high velocity oxygen with humidification. |
At a glance
- 1–9 510(k) clearances
- 1–9 De Novo grants
- None PMA approvals
- None HDE approvals
- 100–999 UDI devices (GUDID)
- 10–99 MAUDE adverse event reports
- 1–9 Recalled products (Z-numbers)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device product codes
FDA product codes classify medical devices by type and intended use; each code maps to a device class, a classification regulation and a review panel.
Source: U.S. Food and Drug Administration (FDA), Product Classification database