Product code
QLN: Extracorporeal system for carbon dioxide removal for the treatment of covid-19
FDA product code · Not Classified · Cardiovascular
Key facts
| Product code | QLN |
|---|---|
| Device | Extracorporeal system for carbon dioxide removal for the treatment of covid-19 |
| Device class | Not Classified |
| Review panel | Cardiovascular |
| Submission type | EUA - Emergency Use Authorization |
| GMP exempt | No |
| Implanted device | No |
| Life-sustaining or life-supporting | Yes |
| Definition | to treat lung failure due to COVID-19 when used as an adjunct to noninvasive or invasive mechanical ventilation in reducing hypercapnia and hypercapnic acidosis due to Coronavirus Disease 2019 (COVID-19), and/or maintaining normalized levels of partial pressure of carbon dioxide (PCO2) and pH in patients suffering from acute, reversible respiratory failure due to COVID-19 for whom ventilation of… |
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
- 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