Device Dossier
Celsite Safety Venous Access Port Si - Port, infusion, implantable
Device Dossier for Celsite Safety Venous Access Port Si - Port, infusion, implantable (Port, infusion, implantable, Class III, sponsor B Braun). ARTG…
- GMDN category: Port, infusion, implantable
- Sponsor: B Braun
Intended purpose
The Celsite® Safety Venous Access Port System is intended to be used for repeated intra-venous administration of, for example, chemotherapy, antibiotic and anti-viral drugs, total parenteral nutrition, blood sampling or transfusion. CT marked access ports may be used for contrast enhanced CT using a high pressure injection.
Functional description
The Celsite Safety Venous Access Port System is a totally implantable device for vascular access. The system consists of an access port, with a silicone septum, which is connected to a catheter. The catheter may be made of Silicone (Si) or Polyurethane (PUR). Access to the system is via percutaneous injection using a special non-coring needle. Both the port and the catheter are radiopaque. The catheter is marked every cm starting at 5cm. This system includes the silicone(Si) catheter.