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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device indicator, physical/chemical, storage temperature
Regulation Description Sterilization process indicator.
Definition The time-temperature indicator provides a visual signal that a selected time-temperature profile has been exceeded. When affixed to a device, a time temperature indicator is indicated, via a permanent color change, for the purpose of distinguishing between medical products that have exceeded a selected time-temperature profile of interest to the user from products that have not exceeded that profile.
Product CodeOCI
Regulation Number 880.2800
Device Class 2


Premarket Reviews
ManufacturerDecision
TEMPTIME CORPORATION
  SUBSTANTIALLY EQUIVALENT 1

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