A portable, reusable thermal-insulating device designed to serve as a cap of, or contain, an autoinjector (e.g., insulin pen), in order to maintain its contents within a specific…
A portable, reusable thermal-insulating device designed to serve as a cap of, or contain, an autoinjector (e.g., insulin pen), in order to maintain its contents within a specific temperature range while being carried by the patient. It is in the form of a small cylinder, which may also function as a cap for the autoinjector, and is made of thermal-insulating material and a phase change material (PCM). It includes electronics that provides indication of medication temperature.
Who Else Makes It
Concentrated in Zhejiang (3), Shanghai (2), Guangdong (1).
Record
Regulatory record for Vivi CAP | Listed by | Tempramed, United States |
| FDA product code | OJL |
| Device type | Insulin Vial Protector/Holder |
| Device class | Class 1 |
| Regulation | 21 CFR 890.5050 |
| Establishment | Specification developer, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2022-04-14 |
Specifications
Specifications | MRI safety | Labeling does not contain MRI Safety Information |
| Over the counter | Yes |
| Label carries | lot or batch number, manufacturing date, serial number |
| Storage | Storage environment temperature -10 to 60 °C |
| Packaging | Case of 10, inner pack of 9, inner pack of 6, inner pack of 5 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.