Indicator, Physical/Chemical, Storage Temperature
- US Product Code (FDA)
- OCIView Product Code Classification →
- US Risk Class (FDA)
- Class 2
- US Regulation (CFR)
- 21 CFR 880.2800View CFR Regulation →
- Medical specialty
- General Hospital
- GMP exempt
- No
- Implantable
- No
- Life-sustaining
- No
- Third party review
- Eligible
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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Indicator, Physical/Chemical, Storage Temperature is a medical device type in the General Hospital specialty. This page includes real-world medical device registration data worldwide for this device type, with registrations from US FDA, Brazil ANVISA, and other global markets.
View regulatory classifications, recent 510(k) clearances, active device registrations, and similar products registered globally under this device category. Pure Global AI's free directory provides comprehensive worldwide registration intelligence across 7,000+ medical device types and 21 specialties.