Product code
NOU: Continuous, ventilator, home use
FDA product code · Class II · Anesthesiology
Key facts
| Product code | NOU |
|---|---|
| Device | Continuous, ventilator, home use |
| Device class | Class II |
| Regulation number | 868.5895 |
| Review panel | Anesthesiology |
| Medical specialty | Anesthesiology |
| Submission type | 510(k) |
| GMP exempt | No |
| Implanted device | No |
| Life-sustaining or life-supporting | Yes |
| Definition | This product code was needed for the home use indication. CBK is not a tracked device and NOU is a tracked device. |
At a glance
- 1–9 510(k) clearances
- None De Novo grants
- None PMA approvals
- None HDE approvals
- 100–999 UDI devices (GUDID)
- 1,000+ MAUDE adverse event reports
- 10–99 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