Product code
QLM: Intensive care unit, respiratory failure and hemodynamic instability tool
FDA product code · Not Classified · Cardiovascular
Key facts
| Product code | QLM |
|---|---|
| Device | Intensive care unit, respiratory failure and hemodynamic instability tool |
| Device class | Not Classified |
| Review panel | Cardiovascular |
| Submission type | EUA - Emergency Use Authorization |
| GMP exempt | No |
| Implanted device | No |
| Life-sustaining or life-supporting | No |
| Definition | To be used by healthcare providers in the Intensive Care Unit (ICU) for adult patients for the computation of patient status indices as an adjunct to patient monitoring during the 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