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 categorySensor, glucose, invasive, non-adjunctive
Device ID00763000721350
MRI safetyLabeling does not contain MRI Safety Information