Device Dossier

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

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

Intended purpose

The BioFlo™ Hybrid PICC with ENDEXO™ and PASV™ Valve Technology with Stainless Steel Guidewire 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 provided as a Modified Seldinger Technique (MST) catheter kit that includes a 70cm SS guidewire. It has a radiopaque, polyurethane catheter with luer lock hubs, extension tubes and suture wing capable of power injection. The PASV valve is located with hub of valved lumens. Valve remains closed when catheter not in use or subjected to normal CVP. The valve opens when positive fluid pressure is applied (infusion). The valve also opens when negative pressure is applied (aspiration).

TGA Public Summary