Product code
QOT: Emergency ventilator
FDA product code · Not Classified · Ear Nose & Throat
Key facts
| Product code | QOT |
|---|---|
| Device | Emergency 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 | A continuous ventilator (respirator) is a device intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas during emergency and/or transfer use. Device is intended to be used temporarily and/or in emergency situations 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)
- 1–9 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