Device Dossier

SAGE Warming Kit - In vitro fertilization culture medium kit

Device Dossier for SAGE Warming Kit - In vitro fertilization culture medium kit (In vitro fertilization culture medium kit, Class III, sponsor Origio).…

Intended purpose

Intended for warming of human oocytes (MII), cleavage stage embryos and blastocysts.

Functional description

Contains 3 solutions, 1.0 M Sucrose Warming solution, 0.5 M Sucrose Warming solution & MOPS solution. Specimen to be warmed is transferred from vitrification carrier into 1.0 M Sucrose Warming solution at 35-37 degrees for 1 minute before transfer to 0.5 M Sucrose Warming solution for 3 minutes. Then moved to 2 successive drops of MOPS solution each for 5 minutes before transfer to preferred media.

TGA Public Summary