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Indicator, Physical/Chemical, Storage Temperature

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.

Global Registration Data
Multi-Country Intelligence
Indicator, Physical/Chemical, Storage Temperature
General Hospital Medical Device Type
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Regulatory Classifications

US Regulatory Classifications

OCI

View Product Code Classification

Class 2

21 CFR 880.2800

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General Hospital

Device Characteristics

No

No

No

Eligible

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.

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