OCI — Indicator, Physical/Chemical, Storage Temperature Class II
FDA product code OCI covers "Indicator, Physical/Chemical, Storage Temperature", a Class II medical device regulated under 21 CFR 880.2800. Submissions are reviewed by the General Hospital panel. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- OCI
- Device Class
- Class II
- Regulation Number
- 880.2800
- Submission Type
- Review Panel
- HO
- Medical Specialty
- General Hospital
- Implant
- No
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K063759 | temptime corporation | HEATMARKER TIME TEMPERATURE INDICATOR | August 15, 2007 |