Device typeImplantable glucose monitoring system: An assembly of portable, battery-powered devices intended to continuously monitor interstitial fluid glucose concentrations in a patient with diabetes mellitus, using an invasive technique. It typically consists of a sterile, subcutaneously-implanted sensor with dedicated implantation devices (e.g., blunt dissector, introducer needle), and an externally worn 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 aids in the detection of episodes of hyperglycaemia and hypoglycaemia, facilitating acute/long-term therapy adjustments.
FDA categoryContinuous Glucose Monitor, Implanted, Adjunctive Use, Sensor, Glucose, Implanted, Non-Adjunctive Use
Device ID00817491021298
Catalog numberFG-6401-01-300
AvailabilityPrescription
Single useYes
MRI safetyLabeling does not contain MRI Safety Information