Device Dossier

MediCult Vitrification Warming - In vitro fertilization culture medium kit

Device Dossier for MediCult Vitrification Warming - In vitro fertilization culture medium kit (In vitro fertilization culture medium kit, Class III,…

Intended purpose

For warming of human oocytes, cleavage stage embryos and blastocysts. This product is for Assisted Reproductive Technology (ART) laboratory procedures. The product should only be used by professionals trained in ART treatment.

Functional description

Consists of 4 solutions, Warming medium (WmM), Dilution medium 1 & 2 (DM1 & DM2), Washing medium (WsM). Oocytes, cleavage stage embryos or blastocysts are taken from vitrification carrier, transferred to WmM for 1-3 min @ 37°C, DM 1 for 3 min @ Room Temperature, DM2 for 3 min @ Room Temperature and WsM for 3 min. Serves to gradually remove cryoprotectants and rehydrate oocytes as they thaw from deep freeze.

TGA Public Summary