Device Dossier
Intravenous catheter holder
Device Dossier for Intravenous catheter holder (Intravenous catheter holder, Class IIa, sponsor Medical Specialties). ARTG record, intended purpose, GMDN…
- GMDN category: Intravenous catheter holder
Intended purpose
Catheter securement adhesive to be applied as a film forming securement and sealant at the point of vascular access (catheter skin entry). The film holds the catheter to the skin to reduce catheter movement, migration, and/or dislodgment. It is used to protect the catheter skin entry site by creating a sealant that immobilizes surface bacteria, preventing them from entering into the catheter skin entry site while also providing a moisture barrier. The device is supplied sterile and is intended for single-use. It is intended to be used with a transparent film dressing [supplied separately] for the securement of short-term and long-term vascular access catheters including peripheral IVs, PICCs and CVCs.