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 a single-use, disposable device intended to be paired with a compatible transmitter as part of a continuous glucose monitoring (CGM) system for the management of diabetes. The sensor and transmitter CGM system is a non-adjunctive system that may replace fingerstick blood glucose readings for treatment decisions. The Sensor is indicated for single patient use in persons 2 years and older with diabetes mellitus.