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 B
| Device Type ID | 2709 |
| Device Name | Indicator, Physical/chemical, Storage Temperature |
| 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 |
| 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 Description | Sterilization Process Indicator. |
| Regulation Medical Specialty | General Hospital |
| Review Panel | General Hospital |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Anesthesiology, General Hospital, Infection Control, And Dental Devices (DAGRID) General Hospital Devices Branch (GHDB) |
| Submission Type | 510(k) |
| CFR Regulation Number | 880.2800 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | OCI |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 2709 |
| Device | Indicator, Physical/chemical, Storage Temperature |
| Product Code | OCI |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Sterilization Process Indicator. |
| CFR Regulation Number | 880.2800 [🔎] |