Device Dossier

Medicine administration kit, percutaneous, medicated, single-use

Device Dossier for Medicine administration kit, percutaneous, medicated, single-use (Medicine administration kit, percutaneous, medicated, single-use,…

Intended purpose

The procedure pack consists of: -Medicine vial and diluent -Mix-2-vial (filter transfer set), -Venipuncture set, -Disposable syringe, -Alcohol Swabs and -Plaster/Adhesive bandage. The Mix-2-vial is used to transfer the diluent from the diluent vial to the medicine vial. The reconstituted medicine is drawn through the Mix-2-vial into the syringe. The syringe containing the medicine is then connected to the venipuncture set to facilitate intravenous injection of the medicine. Alcohol swabs are provided to wipe the rubber stopper of each vial before the Mix-2-vial is applied. The plaster/adhesive bandage is provided to cover the injection site after administration of medicine.

TGA Public Summary