FDA device listing
BurnFree,Water-Jel First Responder HA,Water-Jel Military,Water-Jel Tactical
FDA device listing 1331582711 · Safeguard US Holdco INC
Key facts
| Proprietary names | BurnFree,Water-Jel First Responder HA,Water-Jel Military,Water-Jel Tactical |
|---|---|
| Owner/operator | Safeguard US Holdco INC |
| Owner/operator number | 1219592 |
| Product codes | FPY |
| Device names | FPY - Sheet, Burn |
| Device class | Class I |
| Classification regulations (21 CFR) | 880.5180 |
| Review panels | General Hospital |
| Registered establishments | Water-Jel Technologies, LLC |
| Establishment registrations | 1219592 |
| FEI numbers | 1219592 |
| Establishment operations | Manufacturer |
| 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