FDA device listing
Neutral Luer Activated Device (One-Link Needle-free IV Connector) and Extension Sets with One-Link Needle-free IV…
FDA device listing 1796737160 · BAXTER HEALTHCARE CORPORATION
Key facts
| Proprietary names | Neutral Luer Activated Device (One-Link Needle-free IV Connector) and Extension Sets with One-Link Needle-free IV Connec,One-Link |
|---|---|
| Owner/operator | BAXTER HEALTHCARE CORPORATION |
| Owner/operator number | 1417572 |
| Premarket submissions | K132734 |
| 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 | BAXTER HEALTHCARE CORPORATION, Baxter Healthcare of Puerto Rico LLC, Baxter Healthcare, S.A., Baxter Limited, BAXTER PRODUCTOS MEDICOS, LTDA. |
| Establishment registrations | 1416980, 2649614, 8040700, 9612052, 3003704957 |
| FEI numbers | 1416980, 2649614, 3002806443, 3002806588, 3003704957 |
| Establishment operations | Complaint File Establishment, Specification Developer, Manufacturer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- 10–99 UDI devices (GUDID) under the same submission
- 10–99 Device listings citing the same submission
- Yes 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