Product code
QLD: Protective barrier enclosure
FDA product code · Not Classified · General Hospital
Key facts
| Product code | QLD |
|---|---|
| Device | Protective barrier enclosure |
| 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 transparent device designed to cover a patient's head and upper body and incorporates one or more ports through which the HCP's hands are passed to perform medical procedures. Device provides extra layer of barrier protection, in addition to PPE, 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)
- 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