FDA device listing
ACCESS KIT,ACCESS TRAY,AGBA PICC,AGBA PI MIDLINE,AGBA PI PICC KIT,AM/AT PI MIDLINE,AM PICC SET,ARROW(R) VPS(R) ACCESS…
FDA device listing 1255689570 · Arrow International LLC (subsidiary of Teleflex Incorporated
Key facts
| Proprietary names | ACCESS KIT,ACCESS TRAY,AGBA PICC,AGBA PI MIDLINE,AGBA PI PICC KIT,AM/AT PI MIDLINE,AM PICC SET,ARROW(R) VPS(R) ACCESS KIT,CG+ PICC SET,CVC KIT,CVC SET,INTRAVENOUS SET,LBCVC KIT,MIDLINE CATHETER KIT,MULTI LUMEN CVC KIT,MULTILUMEN PI CVC KIT,PI AGBA PICC KIT,PI CATHETER,PICC KIT,PICC SET,PI CG+ PICC SET,PI CVC KIT,PI CVC SET,PI JACC KIT,PI MIDLINE,PI MULTI LUMEN CVC,PI PICC,PREP KIT,PREP TRAY,QUAD… |
|---|---|
| Owner/operator | Arrow International LLC (subsidiary of Teleflex Incorporated |
| Owner/operator number | 2518433 |
| Product codes | OWL |
| Device names | OWL - Peripheral Catheter Insertion Kit |
| 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, LLC (subsidiary of Teleflex Incorporated) |
| Establishment registrations | 9680794, 3006425876, 3015859709 |
| FEI numbers | 3003737899, 3006425876, 3015859709 |
| Establishment operations | 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