| Device |
indicator, physical/chemical, storage temperature |
| 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 Code | OCI |
|---|
| Premarket Review |
Drug Delivery and General Hospital Devices, and Human Factors
(DHT3C)
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
Reporting |
Ineligible |
| Implanted Device? |
No
|
|---|
| Life-Sustain/Support Device? |
No
|
|---|
|
Third Party Review
|
Accredited Persons
|
