Device Dossier

B Devices Central Venous Catheter Kit - Central venous catheterization kit, short-term

Device Dossier for B Devices Central Venous Catheter Kit - Central venous catheterization kit, short-term (Central venous catheterization kit,…

Intended purpose

The ABLE® Central Venous Catheters may be applicable to the one of following therapy: Monitor of central pressure, continuous or discontinuous venous transfusion and blood sampling. The Catheter is surgically penetrated three optional puncture points depended on the clinical requirement with Seldinger Technique. The Insertion Sites are: Internal jugular vein, subclavian vein or femoral vein. The Catheter insertion time should be no more than 30 days. If the duration exceeds 30 days, there will be a risk of combining the catheter and inside tissue, which result in serious incident.

Functional description

Central Venous Catheters (CVC) are a sterile, single use range of short-term polyurethane catheters designed to facilitate infusion therapy in a critical care environment. The multi lumen variants provide dedicated lumens for infusion therapy, pressure monitoring and venous sampling. Multi-lumen CVC with leur lock connection, centimeter markings and pressure injection capability for CT scanning.

TGA Public Summary