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 venous,…

Intended purpose

PICC (catheter) intended for peripheral access to the central venous system for short (< 30 days) or long-term (≥ 30 days) vascular access for the intended duration according to the indication for use. The PICC is intended to be used for diagnostic and/or therapeutic purposes including, but not limited to the following: · Chemotherapy · IV Fluids · IV Medications · Parenteral Nutrition · Blood Products · Blood Sampling · Administration/Power Injection of Contrast Media* · Central Venous Pressure Monitoring Lumens labeled for power injection may be used for injection of contrast media. Refer to specific parameters within the applicable section of the IFU (Instructions for Use). Lumens labeled "CVP" may be used for central venous pressure monitoring. Refer to specific parameters within the applicable section of the IFU

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 catheter. Packaged in a tray with accessories to assist during catheter insertion that may include: Securement Device, Flush Assembly, Scalpel, Guidewire, Syringe, Stiffening Wire, Tape Measure, Peelable Sheath Dilator, Needle(s), and/or End Cap(s).

TGA Public Summary