Device Dossier
Organ preservation solution
Device Dossier for Organ preservation solution (Organ preservation solution, Class IIa, sponsor Aurora BioScience). ARTG record, intended purpose, GMDN…
- GMDN category: Organ preservation solution
Intended purpose
PumpProtect® is a clear, transparent to slightly yellow, sterile, non-pyrogenic, non-toxic solution intended for the rinsing and mechanical perfusion of an in vitro removed organ (kidneys and liver). The solution has an approximate calculated osmolality of 300 mOsm/kg, a potassium concentration of 25 mmol/L, a sodium concentration of 100 mmol/L, and a pH of approximately 7.4 at room temperature.