OCI

1 FDA 510(k) clearances · Product code

FDA profile

Official device name

Indicator, Physical/Chemical, Storage Temperature

Device class

Class II (moderate risk)

Regulation

21 CFR 880.2800

Medical specialty

General Hospital

Flags

Third-party review eligible

FDA 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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