Device Dossier

Ambulatory insulin infusion pump software, patient-dosing

Device Dossier for Ambulatory insulin infusion pump software, patient-dosing (Ambulatory insulin infusion pump software, patient-dosing, Class IIb,…

Intended purpose

The mobile app is an accessory intended for use as a connected software device that is able to reliably and securely communicate with compatible insulin pumps, including receiving and displaying pump information and sending insulin delivery commands to a user's connected and compatible insulin pump.

TGA Public Summary