Product code
QOS: Continuous ventilator
FDA product code · Not Classified · Ear Nose & Throat
Key facts
| Product code | QOS |
|---|---|
| Device | Continuous ventilator |
| Device class | Not Classified |
| Review panel | Ear Nose & Throat |
| Submission type | EUA - Emergency Use Authorization |
| GMP exempt | No |
| Implanted device | No |
| Life-sustaining or life-supporting | No |
| Definition | Intended to provide continuous ventilatory support for use during declared public health emergency. May be used in hospital or facility settings. |
At a glance
- None 510(k) clearances
- None De Novo grants
- None PMA approvals
- None HDE approvals
- None UDI devices (GUDID)
- 1–9 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