Device Dossier

Unclassified

Device Dossier for Unclassified (Unclassified, Class IIa, sponsor Terumo). ARTG record, intended purpose, GMDN category — compiled by arcimedes.

Intended purpose

as a flow through device inserted directly into the extracorporeal tubing circuit to provide an optical window for the CDI 100 monitor during cardiopulmonary bypass procedures when continuous monitoring of blood hematocrit, hemoglobin and oxygen saturation is desired

TGA Public Summary