DeviceClearance

Product code OCI— General Hospital

HEATMARKER TIME TEMPERATURE INDICATOR

Classification name
Indicator, Physical/Chemical, Storage Temperature
Device class
Class 2
Regulation
21 CFR 880.2800
Advisory panel
General Hospital
Total cleared
1
First cleared
Most recent

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.”

— U.S. Food and Drug Administration, device classification record for product code OCI under 21 CFR 880.2800, via openFDA

Market context for product code OCI

FDA has cleared 1 device under product code OCI, all in 2007, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Top applicants under product code OCI

Recent clearances under product code OCI

Data sourced from openFDA. This site is unofficial and independent of the FDA.