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 for use with a compatible transmitter to monitor glucose levels in persons with diabetes where self-monitoring of blood glucose (SMBG) is indicated. The sensor is designed to replace fingerstick blood glucose (BG) readings for diabetes treatment decisions. The sensor is intended for insertion into persons ages 7 years and older.