Device Dossier

Infusion pump, insulin, ambulatory

Device Dossier for Infusion pump, insulin, ambulatory (Infusion pump, insulin, ambulatory, Class IIb, sponsor Roche Diabetes Care). ARTG record, intended…

Intended purpose

This device is intended exclusively for the continuous delivery of U100 short-acting insulin or fast acting insulin analogue for people with diabetes. This device is also intended to be used in conjunction with the Accu-Chek Performa Combo blood glucose meter (as a remote control)

TGA Public Summary