Product code
QOU: Emergency resuscitator
FDA product code · Not Classified · Anesthesiology
Key facts
| Product code | QOU |
|---|---|
| Device | Emergency resuscitator |
| Device class | Not Classified |
| Review panel | Anesthesiology |
| Submission type | EUA - Emergency Use Authorization |
| GMP exempt | No |
| Implanted device | No |
| Life-sustaining or life-supporting | No |
| Definition | Emergency ventilator incorporating bag and valve, intended to provide emergency respiratory support by means of a face mask or a tube inserted into a patient's airway (may be automated) for use during declared public health emergency. |
At a glance
- None 510(k) clearances
- None De Novo grants
- None PMA approvals
- None HDE approvals
- None UDI devices (GUDID)
- None MAUDE adverse event reports
- None 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