OCIClass II
Indicator, Physical/Chemical, Storage Temperature
21 CFR 880.2800 / General Hospital
OCI is the FDA product code for Indicator, Physical/Chemical, Storage Temperature, a class II device type, regulated under 21 CFR 880.2800. FDA's definition for this code reads: "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...". As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.
Classification record
- Product code
- OCI
- Device name
- Indicator, Physical/Chemical, Storage Temperature
- FDA 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.
- Regulation
- 21 CFR 880.2800
- Device class
- Class II
- Review panel
- General Hospital
- Submission type
- 510(k)
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- Yes
- Ingested clearances
- 1
- Ingested recalls
- 0
Clearances, product code OCI
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 2007 | 1 |
Applicants with the most clearances
Product code OCI| Applicant | Clearances |
|---|---|
| Temptime Corporation | 1 |
Companies listing this code with FDA
Companies whose registered establishments list this codeFIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.