FDA device listing
IncuBlanket - Infant Warming Incubator Blankets,IncuBlanket - Infant Warming Incubator Warmers
FDA device listing 1499454310 · Warmilu
Key facts
| Proprietary names | IncuBlanket - Infant Warming Incubator Blankets,IncuBlanket - Infant Warming Incubator Warmers |
|---|---|
| Owner/operator | Warmilu |
| Owner/operator number | 10055658 |
| Product codes | FPL |
| Device names | FPL - Incubator, Neonatal Transport |
| Device class | Class II |
| Classification regulations (21 CFR) | 880.5410 |
| Review panels | General Hospital |
| Registered establishments | WARMILU LLC |
| Establishment registrations | 3013923269 |
| FEI numbers | 3013923269 |
| Establishment operations | U.S. Manufacturer of Export Only Devices |
| 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