Indicator, Physical/Chemical, Storage Temperature
The Storage Temperature Physical/Chemical Indicator (product code OCI) is a general hospital device that provides a visual signal, via a permanent color change, indicating whether a medical product has exceeded a selected time-temperature profile during storage or transport. When affixed to medical products, it allows users to distinguish between items that have and have not been exposed to potentially damaging temperature conditions. This device is FDA Class 2 under regulation 880.2800 in the General Hospital specialty, requiring 510(k) clearance, and is eligible for third-party review. It carries no implant or life-sustaining flags.
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Basic Information
- Product Code
- OCI
- Device Class
- FDA class 2
- Regulation Number
- 880.2800
- Medical Specialty
- General Hospital
- Review Panel
- HO
- Submission Type
- 1
Device Characteristics
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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 1 510(k) clearance via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K063759 | HEATMARKER TIME TEMPERATURE INDICATOR | Aug 15, 2007 | Substantially Equivalent | Temptime Corporation |
FEI Numbers
This FDA classification entry is associated with 1 FEI number. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 1 registration number. Click on an entry to view related FDA registrations.