Device Dossier

Blood donor set, double-pack

Device Dossier for Blood donor set, double-pack (Blood donor set, double-pack, Class IIb, sponsor LivaNova). ARTG record, intended purpose, GMDN category…

GMDN category: Blood donor set, double-pack

Intended purpose

XTRA Sequestration Set X is intended to be used within the XTRA system for preoperative sequestration, aimed at autotransfusion. The use of the device for preoperative sequestration is intended to separate whole blood into platelet-poor plasma (PPP) and/or platelet-rich plasma (PRP), and red blood cells.

TGA Public Summary