FDA device listing
Prevalon Air Pump,Prevalon AirTAP Glide Sheet,Prevalon AirTAP Patient Repositioning System,Prevalon AirTAP XXL Patient…
FDA device listing 1815198891 · SAGE PRODUCTS LLC
Key facts
| Proprietary names | Prevalon Air Pump,Prevalon AirTAP Glide Sheet,Prevalon AirTAP Patient Repositioning System,Prevalon AirTAP XXL Patient Repositioning System,Prevalon AirTAP XXL Patient Repositioning System Glide Sheet,Prevalon Booster Pump,Prevalon Mobile Air Transfer Mat,Prevalon Mobile Air Transfer System,Prevalon TAP 1.0 Low Friction Glide Sheet,Prevalon TAP 2.0 Low Friction Glide Sheet,Prevalon TAP XL Low… |
|---|---|
| Owner/operator | SAGE PRODUCTS LLC |
| Owner/operator number | 9914017 |
| Product codes | FMR |
| Device names | FMR - Device, Transfer, Patient, Manual |
| Device class | Class I |
| Classification regulations (21 CFR) | 880.6785 |
| Review panels | General Hospital |
| Registered establishments | SAGE PRODUCTS LLC |
| Establishment registrations | 1419181 |
| FEI numbers | 1419181 |
| Establishment operations | Manufacturer, 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