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Indicator, Physical/Chemical, Storage Temperature

FDA product code OCI · 1 cleared devices

Class 2 General Hospital
Regulation
21 CFR 880.2800
Review panel
HO
Implant
No
Life sustaining
No
Third party review
Yes
GMP exempt
No
Clearance span
2007-08-15 – 2007-08-15

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.

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