FDA device listing
AMS-537,AMS-539-2,AMS-539-3,AMS-8182-1,Filter and Fluid Connector,MSPT-010878
FDA device listing 1579152364 · VYGON USA
Key facts
| Proprietary names | AMS-537,AMS-539-2,AMS-539-3,AMS-8182-1,Filter and Fluid Connector,MSPT-010878 |
|---|---|
| Owner/operator | VYGON USA |
| Owner/operator number | 2245270 |
| Product codes | OJA |
| Device names | OJA - Intravenous Extension Tubing Set |
| Device class | Class II |
| Classification regulations (21 CFR) | 880.5440 |
| Review panels | General Hospital |
| Registered establishments | Vygon MFG, VYGON USA |
| Establishment registrations | 1223004, 2245270 |
| FEI numbers | 2245270, 1000120555 |
| Establishment operations | Contract Manufacturer, Contract Sterilizer, Manufacturer, 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