Product code
QLE: Protective barrier enclosure with negative pressure
FDA product code · Not Classified · General Hospital
Key facts
| Product code | QLE |
|---|---|
| Device | Protective barrier enclosure with negative pressure |
| Device class | Not Classified |
| Review panel | General Hospital |
| Submission type | EUA - Emergency Use Authorization |
| GMP exempt | No |
| Implanted device | No |
| Life-sustaining or life-supporting | No |
| Definition | A barrier device with negative pressure which partially or fully covers a patient to prevent HCP exposure to pathogenic biological airborne particulates. These barrier devices include ports for medical care and/or procedures. Device intended to be used 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