Product code
QLO: Immunoadsorption column for emergency use
FDA product code · Not Classified · Gastroenterology/Urology
Key facts
| Product code | QLO |
|---|---|
| Device | Immunoadsorption column for emergency use |
| Device class | Not Classified |
| Review panel | Gastroenterology/Urology |
| Submission type | EUA - Emergency Use Authorization |
| GMP exempt | No |
| Implanted device | No |
| Life-sustaining or life-supporting | Yes |
| Definition | Extracorporeal carbon dioxide removal from blood 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)
- 10–99 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