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iLet Bionic Pancreas

iLet Bionic Pancreas (Commercial Starter Kit)

Details

Device typeAmbulatory insulin infusion pump/interstitial glucose monitoring system: An assembly of portable devices intended to simultaneously continuously monitor interstitial glucose levels and subcutaneously infuse insulin in patients with diabetes. Sometimes referred to as a closed loop artificial pancreas, it consists of a percutaneous blood glucose monitoring system (CGM), an ambulatory insulin infusion pump, and software on a dedicated handset or transmitter capable of telemetric communication with the other components. The software contains an algorithm to allow continuous communication between the two devices, and may enable the manual input of data with respect to meals and physical activity.

FDA categoryAlternate Controller Enabled Insulin Infusion Pump, Interoperable Automated Glycemic Controller

Device ID00850050080046

Catalog numberBB1002

AvailabilityPrescription

MRI safetyMR Unsafe

Contact

Phone855-745-3800

Emailxx@xx.xx

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