FDA device listing
Ag+ Blue Plus ML CVCs,AGB+ Multi-Lumen CVC Kit,AGB+ Quad Lumen CVC Kit,AGB+ Two-Lumen CVC Kit,ARROWg+ard Blue Plus…
FDA device listing 1809284984 · Arrow International LLC (subsidiary of Teleflex Incorporated
Key facts
| Proprietary names | Ag+ Blue Plus ML CVCs,AGB+ Multi-Lumen CVC Kit,AGB+ Quad Lumen CVC Kit,AGB+ Two-Lumen CVC Kit,ARROWg+ard Blue Plus Multi-Lumen CVC Extreme Kit,ARROWg+ard Blue Plus Multi-Lumen CVC Kit,ARROWg+ard Blue Plus Multi-Lumen CVC Set,ARROWg+ard Blue Plus Multi-Lumen CVC Super Kit,ARROWg+ard Blue Plus Quad-Lumen CVC,ARROWg+ard Blue Plus Quad-Lumen CVC Set,ARROWg+ard Blue Plus Quad-Lumen CVC Super… |
|---|---|
| Owner/operator | Arrow International LLC (subsidiary of Teleflex Incorporated |
| Owner/operator number | 2518433 |
| Premarket submissions | K993691 |
| Product codes | FOZ |
| Device names | FOZ - Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days |
| Device class | Class II |
| Classification regulations (21 CFR) | 880.5200 |
| Review panels | General Hospital |
| Registered establishments | Arrow Internacional de Chihuahua S.A. de C.V., Arrow International C.R. a.s., Arrow International CR, a.s., Arrow International, LLC (subsidiary of Teleflex Incorporated) |
| Establishment registrations | 9680794, 1000563940, 3006425876, 3015859709 |
| FEI numbers | 1000563940, 3003737899, 3006425876, 3015859709 |
| Establishment operations | Foreign Exporter, Manufacturer, Repackager/Relabeler, Specification Developer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- 1,000+ UDI devices (GUDID) under the same submission
- 1–9 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