Device Dossier

BioFlo Hybrid PICC with ENDEXO and PASV Valve Technology with Nitinol Guidewire - Catheter, central venous, peripherally inserted

Device Dossier for BioFlo Hybrid PICC with ENDEXO and PASV Valve Technology with Nitinol Guidewire - Catheter, central venous, peripherally inserted…

Intended purpose

The BioFlo™ Hybrid PICC with ENDEXO™ and PASV™ Valve Technology is indicated for short or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications and nutrients; the sampling of blood; and for power injection of contrast media. Non-valved lumens are indicated for central venous pressure monitoring.

Functional description

The device is a radiopaque, polyurethane catheter with luer lock hub(s), polyurethane extension tube(s), and suture wing(s). The lumens are differentiated by colored luer lock hubs that indicate lumen size, maximum flow rates are indicated on clamp(s). Packaged in a tray with accessories that may include a Securement Device, Flush Assembly, Scalpel, Guidewire, Syringe, Stiffening Wire, Tape Measure, Peelable Sheath Dilator, Needle(s), and/or End Cap(s).

TGA Public Summary