Device Dossier
Subcutaneous glucose sensor
Device Dossier for Subcutaneous glucose sensor (Subcutaneous glucose sensor, Class IIb, sponsor Medtronic). ARTG record, intended purpose, GMDN category…
- GMDN category: Subcutaneous glucose sensor
Intended purpose
The sensor is intended to communicate with a software application (App) to provide glucose information for diabetes management. The sensor is designed to replace finger stick blood glucose (BG) readings for diabetes treatment decisions. The sensor is indicated for the management of diabetes in persons ages 2 years and older, or for use by parents/caregivers who assist these individuals with diabetes management.