Device Dossier

Organ preservation solution

Device Dossier for Organ preservation solution (Organ preservation solution, Class IIa, sponsor Stark Medical). ARTG record, intended purpose, GMDN…

Intended purpose

Intended for flushing and hypothermic preservation of thoracic organs (heart and lung) and abdominal organs (kidney, liver, pancreas) during transplantation. The solution is to be used to flush the isolated organ immediately before, after removal from a dead donor or immediately after removal from a living donor. This is sterile device.

TGA Public Summary