FDA device listing
AVALON AIRE HEADSTRAP
FDA device listing 1962913849 · PEPPER MEDICAL, INC.
Key facts
| Proprietary names | AVALON AIRE HEADSTRAP |
|---|---|
| Owner/operator | PEPPER MEDICAL, INC. |
| Owner/operator number | 9006041 |
| Product codes | BTK |
| Device names | BTK - Strap, Head, Gas Mask |
| Device class | Class I |
| Classification regulations (21 CFR) | 868.5560 |
| Review panels | Anesthesiology |
| Registered establishments | PEPPER MEDICAL, INC. |
| Establishment registrations | 2529776 |
| FEI numbers | 1000121196 |
| Establishment operations | Repackager/Relabeler, Specification Developer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- None listed Premarket submission listed
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device listings
Establishments that make or process devices for the U.S. market must list each device with the FDA. A listing records the device's proprietary names, product codes and premarket submission, and every registered establishment that handles it.
Source: U.S. Food and Drug Administration (FDA), Establishment Registration and Device Listing database