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,…
- GMDN category: Catheter, central venous, peripherally inserted
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 hubs, extension tubes and suture wing. The valve (PASV) 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. Packaged in a tray with accessories that may include: Securement Device, Flush Assembly, Scalpel, Guidewire, Syringe, Stiffening Wire, Tape Measure, Peelable Sheath Dilator, Needle(s), etc.