MDS

Sensor, Glucose, Invasive

Product code

MDS

Device name

Sensor, Glucose, Invasive

Device class

Class 3

Medical specialty

Unknown

Marketing pathway

PMA

FDA classification definition

The device is a glucose-monitoring device indicated for detecting trends and tracking patterns in adults (age 18 and older) with diabetes. The device is indicated for use as an adjunctive device to complement, not replace, information obtained from standard home glucose monitoring devices. The system aids in the detection of episodes of hyperglycemia and hypoglycemia, facilitating both acute and long-term therapy adjustments.

Definition text from the FDA device classification database (U.S. federal government work, public domain).