Device typePercutaneous interstitial fluid glucose monitoring system, electrochemical: An assembly of electrically-powered, portable devices intended to continuously monitor interstitial fluid glucose concentrations in a patient with diabetes mellitus, using an invasive electrochemical technique. It consists of an electrochemical, percutaneously-inserted electrode that physically connects to a cable or transmitter which communicates with a monitor or receiver (not included) that captures, stores, and converts the sensor signals to glucose concentrations for display. The system may be used in the home and clinical settings, and aids in the detection of episodes of hyperglycaemia and hypoglycaemia, facilitating acute/long-term therapy adjustments.
FDA categoryIntegrated Continuous Glucose Monitor For Non-Intensive Glucose Monitoring, Over-The-Counter
Device ID00386270004338
AvailabilityOver the counter
Single useYes
SterileYes
MRI safetyMR Unsafe