Device Dossier
Pro- Fuse CT Power Injectable Infusion Port with Polyurethane Catheter - Port, infusion, implantable
Device Dossier for Pro- Fuse CT Power Injectable Infusion Port with Polyurethane Catheter - Port, infusion, implantable (Port, infusion, implantable,…
- GMDN category: Port, infusion, implantable
Intended purpose
Medcomp's Pro-fuse CT Power Injectable Infusion Port is indicated for patient therapies that require repetitive access to the vascular system. The port system may be used for blood withdrawal , infusion of medications, I.V. fluids, and parenteral nutrition solutions. The device is also intended for use with high pressure injection of contrast agents for Contrast Enhanced Tomography (CECT) scans. The Pro-Fuse CT Power Injectable Infusion Port is intended for use greater than 30 days. The Pro-Fuse CT Power Injectable Infusion Port is capable of high pressure injection of contrast agents for Contrast Enhanced Computed (CECT) scans at a rate of 5ml/sec with 300psi pressure limit using 19 and 20 gauge non-coring needles and 2ml/sec with a 300psi pressure limit using 22 gauge non- coring needles.
Functional description
an implantable access device designed to provide repeated access to the vascular system. Performed by percutaneous needle insertion. Consists of two primary components - an injection port with a self sealing polyurethane septum and radiopaque catheter. All materials are biocompatible and can be used with virtually all injectable solutions, are latex free and safe with CERT and MRI imaging".