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twiist

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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 categoryInteroperable Automated Glycemic Controller

Device ID00850017421431

AvailabilityPrescription

Single useYes

SterileYes

MRI safetyMR Unsafe

Contact

Phone877-489-4478

Phone603-206-0591

Emailsupport@sequelmedtech.com

Emailqa@millyardadvanced.com

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