FDA device listing
2- Lumen PICC Products w/ Blue Flex,Peripherally inserted central catheter (PICC) Product with Blue Flex Tip and…
FDA device listing 1053719691 · Arrow International LLC (subsidiary of Teleflex Incorporated
Key facts
| Proprietary names | 2- Lumen PICC Products w/ Blue Flex,Peripherally inserted central catheter (PICC) Product with Blue Flex Tip and integral needle protection,Peripherally Inserted central catheter (PICC) with Blue |
|---|---|
| Owner/operator | Arrow International LLC (subsidiary of Teleflex Incorporated |
| Owner/operator number | 2518433 |
| Premarket submissions | K003006 |
| Product codes | LJT |
| Device names | LJT - Port & Catheter, Implanted, Subcutaneous, Intravascular |
| Device class | Class II |
| Classification regulations (21 CFR) | 880.5965 |
| 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 | Foreign Exporter, Manufacturer, Repackager/Relabeler, Specification Developer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- 10–99 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