Device Dossier

Intravenous catheter holder

Device Dossier for Intravenous catheter holder (Intravenous catheter holder, Class IIa, sponsor Medical Specialties). ARTG record, intended purpose, GMDN…

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.

TGA Public Summary