Device Dossier

Blood collection/cell-culture container

Device Dossier for Blood collection/cell-culture container (Blood/tissue storage/culture container, Class IIa, sponsor Miltenyi Biotec). ARTG record,…

Intended purpose

The CryoMACS Freezing Bags are intended for a single cycle of freezing, storage (down to -196 degrees celsius) and subsequent thawing (at +37 degrees celsius) of hemotopoietic progenitor cells. Each bag consists of one freezing bag with access ports as the primary containment for blood components and one overwrap bag as a secondary containment.

TGA Public Summary