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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device injection data capture device
Definition An injection data capture device is an electrically-powered/electromechanical accessory that interfaces with reusable or disposable injection devices for the purposes of interpreting, recording and displaying and/or transmitting injection data to a connected application or software.
Product CodeQOG
Regulation Number 880.5860
Device Class 2


Premarket Reviews
ManufacturerDecision
BIOCORP PRODUCTION
  SUBSTANTIALLY EQUIVALENT 2
ELI LILLY AND COMPANY
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2022 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Hypoglycemia 1 1
Confusion/ Disorientation 1 1

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