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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device insulin pump secondary display
Regulation Description Continuous glucose monitor secondary display.
Definition The purpose of the insulin pump secondary display is to notify another person of the patient's insulin pump usage information in real time. The secondary display is intended for providing secondary notification of insulin pump usage and does not replace primary real time insulin pump monitoring or standard home blood glucose monitoring.
Product CodePKU
Regulation Number 862.1350
Device Class 2