Device Dossier

Organ preservation solution

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

Intended purpose

StoreProtect® is a clear, transparent to slightly yellow, sterile, non-pyrogenic, non-toxic solution intended for hypothermic perfusion and storage of organs (kidneys, liver, pancreas). StoreProtect® has an osmolality of approximately 320 mOsm/kg, a sodium concentration of 29 mmol/L, a potassium concentration of 125 mmol/L, and a pH of approximately 7.4 at room temperature.

TGA Public Summary