OCI · Class II · 21 CFR 880.2800

FDA Product Code OCI: Indicator, Physical/chemical, Storage Temperature

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.

1
Total
1
Cleared
239d
Avg days
2007
Since

FDA 510(k) Cleared Indicator, Physical/chemical, Storage Temperature Devices (Product Code OCI)

1 devices
1–1 of 1
No devices found for this product code.

About Product Code OCI - Regulatory Context