FDA device listing
BioFlo Hybrid PICC with ENDEXO and PASV Valve Technology-Maximal Barrier Nursing Kit,BioFlo PICC with ENDEXO and PASV…
FDA device listing 1971797690 · ANGIODYNAMICS, INC
Key facts
| Proprietary names | BioFlo Hybrid PICC with ENDEXO and PASV Valve Technology-Maximal Barrier Nursing Kit,BioFlo PICC with ENDEXO and PASV Valve Technology-Maximal Barrier Nursing Kit,BioFlo PICC with ENDEXO Technology-Maximal Barrier Nursing Kit,Xcela Power Injectable PICC Maximal Barrier Nursing Kit |
|---|---|
| Owner/operator | ANGIODYNAMICS, INC |
| Owner/operator number | 9028212 |
| Premarket submissions | K163452 |
| Product codes | LJS, PND |
| Device names | LJS - Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days, PND - Midline Catheter |
| Device class | Class II |
| Classification regulations (21 CFR) | 880.5200, 880.5970 |
| Review panels | General Hospital |
| Registered establishments | ANGIODYNAMICS, INC, ANGIODYNAMICS, INC. |
| Establishment registrations | 1319211, 3015537049 |
| FEI numbers | 1319211, 3015537049 |
| Establishment operations | Contract Manufacturer, Repackager/Relabeler |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- None 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