Device Dossier

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

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

Intended purpose

The BioFlo™ 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 with leur lock hub(s), extension tube(s) and suture wing. Lumens are differentiated by coloured luer lock hubs that indicate lumen size and indicate power or non-power injectable lumens. The PASV valve is within hub and remains closed when not in use. When positive pressure is applied, valve opens allowing for infusion. When negative pressure applied valve opens for withdrawal of blood.

TGA Public Summary