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U.S. Department of Health and Human Services

Product Classification

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Device indicator, physical/chemical, storage temperature
Regulation Description Sterilization process indicator.
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.
Physical State Plastic label stock, with adhesive backing. Reference and active inks are deposited upon the plastic stock. The reference ring is printed with UV curable ink or a solvent-based ink, depending on the substrate. The active ink contains a suspension of diacetylenic monomers within a nitrocellulose-based ink vehicle.
Technical Method The mode of operation is through the solid state polymerization of diacetylenes (DAs) to form poly(diacetylenes) (PDAs).
Target Area Affixed to packaging of a device.
Regulation Medical Specialty General Hospital
Review Panel General Hospital
Product CodeOCI
Premarket Review Office of Gastrorenal, ObGyn, General Hospital, and Urology Devices (OHT3)
Drug Delivery and General Hospital Devices, and Human Factors (DHT3C)
Submission Type 510(k)
Regulation Number 880.2800
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review
Accredited Persons