Product code OCI

Device name
Indicator, Physical/Chemical, Storage Temperature
Medical specialty
General Hospital
Device class
2
Regulation number
880.2800
Review panel
HO
Implant
N
Life sustaining/supporting
N
GMP exempt
N
Third party review
Y
Summary malfunction reporting
Ineligible
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.
Source
FDA openFDA device classification dataset