Device Dossier
Basic intravenous administration set, invasive
Device Dossier for Basic intravenous administration set, invasive (Basic intravenous administration set, invasive, Class IIa, sponsor CSL Behring). ARTG…
- GMDN category: Basic intravenous administration set, invasive
- Sponsor: CSL Behring
Intended purpose
The procedure pack consists of: Medicine vial, a diluent vial, Mix2Vial, disposable syringe (10 mL (500 IU), or 5 mL (1500 IU)), winged infusion (venipuncture) set 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 syringe containing the medicine is then connected to the winged infusion (venipuncture) set to facilitate intravenous injection of the medicine. The alcohol swab is used to disinfect the stoppers.