Product code
QOO: Ventilator tubing and accessories
FDA product code · Not Classified · Ear Nose & Throat
Key facts
| Product code | QOO |
|---|---|
| Device | Ventilator tubing and accessories |
| Device class | Not Classified |
| Review panel | Ear Nose & Throat |
| Submission type | EUA - Emergency Use Authorization |
| GMP exempt | No |
| Implanted device | No |
| Life-sustaining or life-supporting | No |
| Definition | Accessories used with non-continuous ventilators (may include Ventilator Tubing Connector, Elbow Connector for Mask, Breathing Attachment devices) 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)
- 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