OCI

Indicator, Physical/Chemical, Storage Temperature

Product code

OCI

Device name

Indicator, Physical/Chemical, Storage Temperature

Device class

Class 2

21 CFR

21 CFR 880.2800

Medical specialty

General Hospital

Marketing pathway

510(K)

Flag

Third-party review eligible

510(k) clearances (all years, FDA)

1 (all years; only the last 3 years are listed here)

FDA classification 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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).