Device Dossier
Vial adaptor, hermetic
Device Dossier for Vial adaptor, hermetic (Vial adaptor, hermetic, Class IIa, sponsor ICU Medical). ARTG record, intended purpose, GMDN category —…
- GMDN category: Vial adaptor, hermetic
Intended purpose
A sterile device intended to be fitted to a vial to allow the airtight removal of vial contents into a syringe, for subsequent application to a patient. It is typically a housing that attaches to or replaces the vial lid and incorporates a sealed expansion chamber (e.g., balloon) allowing for closed pressure equalization intended to prevent the egress and ingress of materials (e.g., vapours, microbes). This is a single-use device.