Device Dossier

BioFlo PICC with ENDEXO Technology with Stainless Steel Guidewire - MST Kit - Catheterization kit, central venous

Device Dossier for BioFlo PICC with ENDEXO Technology with Stainless Steel Guidewire - MST Kit - Catheterization kit, central venous (Catheterization…

Intended purpose

The BioFlo™ 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 a Modified Seldinger Technique (MST) kit with a 70cm wire and a radiopaque polyurethane catheter with luer lock hubs, extension tubes and suture wing. Lumens are differentiated by coloured luer lock hubs that indicate lumen size and power or non-powered 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