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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device interoperable automated glycemic controller, insulin suspend
Definition An interoperable automated glycemic controller, insulin suspend, is a device that temporarily suspend and resumes insulin infusion from a connected infusion pump based on specified thresholds and input glucose levels. Interoperable automated glycemic controllers, insulin suspend, are designed to reliably and securely communicate with digitally connected devices to allow insulin delivery suspension and resumption commands to be sent, received, executed, and confirmed. Interoperable automated glycemic controllers, insulin suspend, are intended to be used in conjunction with digitally connected devices for the purpose of maintaining glycemic control.
Product CodeQJS
Regulation Number 862.1356
Device Class 2


Premarket Reviews
ManufacturerDecision
TANDEM DIABETES CARE, INC.
  SUBSTANTIALLY EQUIVALENT 1

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