FDA device listing
ACCESS TRAY,CVC KIT,CVC/PSI KIT,CVC SET,LBCVC KIT,MULTILUMEN CVC KIT,MULTILUMEN PI CVC KIT,PI CATHETER,PI CVC KIT,PI CVC…
FDA device listing 1314948882 · Arrow International LLC (subsidiary of Teleflex Incorporated
Key facts
| Proprietary names | ACCESS TRAY,CVC KIT,CVC/PSI KIT,CVC SET,LBCVC KIT,MULTILUMEN CVC KIT,MULTILUMEN PI CVC KIT,PI CATHETER,PI CVC KIT,PI CVC KIT AGB+ |
|---|---|
| Owner/operator | Arrow International LLC (subsidiary of Teleflex Incorporated |
| Owner/operator number | 2518433 |
| Product codes | LRS |
| Device names | LRS - I.V. Start 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. |
| Establishment registrations | 9680794 |
| FEI numbers | 3003737899 |
| Establishment operations | Manufacturer |
| 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