FDA device listing
T030-000 IV Set,T090-000 IV Set,T090-000V IV Set,T090-000W IV Set,T090-022V IV Set,T090-022W IV Set,T095-022 IV…
FDA device listing 1514570710 · VYGON USA
Key facts
| Proprietary names | T030-000 IV Set,T090-000 IV Set,T090-000V IV Set,T090-000W IV Set,T090-022V IV Set,T090-022W IV Set,T095-022 IV Set,T095-120 IV Set,T100-000F IV Set,T100-000VF IV Set,T100-000WF IV Set,T100-022F IV Set,T100-120F IV Set,T105-000WC Set |
|---|---|
| Owner/operator | VYGON USA |
| Owner/operator number | 2245270 |
| Product codes | FPA |
| Device names | FPA - Set, Administration, Intravascular |
| Device class | Class II |
| Classification regulations (21 CFR) | 880.5440 |
| Review panels | General Hospital |
| Registered establishments | Vygon MFG |
| Establishment registrations | 1223004 |
| FEI numbers | 1000120555 |
| Establishment operations | Contract Manufacturer, Contract Sterilizer |
| 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