FDA device listing
50 cm Low Pressure Connector Tube
FDA device listing 1950608922 · Bayer Medical Care Inc.
Key facts
| Proprietary names | 50 cm Low Pressure Connector Tube |
|---|---|
| Owner/operator | Bayer Medical Care Inc. |
| Owner/operator number | 2520313 |
| Product codes | FPK |
| Device names | FPK - Tubing, Fluid Delivery |
| Device class | Class II |
| Classification regulations (21 CFR) | 880.5440 |
| Review panels | General Hospital |
| Registered establishments | Bayer Medical Care Inc. |
| Establishment registrations | 2520313 |
| FEI numbers | 2520313 |
| 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