Device Dossier
Medication transfer set
Device Dossier for Medication transfer set (Medication transfer set, Class IIb, sponsor CSL Behring). ARTG record, intended purpose, GMDN category —…
- GMDN category: Medication transfer set
- Sponsor: CSL Behring
Intended purpose
The procedure pack consists of: Medicine vial, a diluent vial, Mix2Vial, silicone-free disposable syringe (5 mL (2000 IU), or 10 mL (3000 IU)), subcutaneous injection set, a hypodermic needle and an alcohol swab, all sterile. The Mix2Vial transfer device is used for both, transfer of sterile water for injection into the product vial and filtering of the reconstituted product before withdrawal into a syringe. The disposable syringe is connected to the Mix2Vial and used to draw the solution. The alcohol swab is used to disinfect the stoppers. As required and instructed by the doctor, either the needle or subcutaneous injection is used to administer the reconstituted product.