Device Dossier

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

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

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, nutrients; the sampling of blood; for central venous pressure monitoring and for power injection of contrast media.

Functional description

The device is a catheter kit configuration with a 55cm radiopaque polyurethane catheter capable of power injection. The lumens are differentiated by color; maximum power injection flow rates are indicated on the clamp(s). The PASV Valve is located in the luer hub of the valved lumen and remains closed when catheter is not in use/subjected to CVP. The valve opens when positive pressure is applied (infusion), and when negative pressure is applied (aspiration). Guidewires can be used in any lumen.

TGA Public Summary