Vivi CAP Smart
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. Additionally, it has an incorporated timer mechanism to help people know how long it has been since they last took their medication and an optional connected cell phone application used as a log book to store the time information and amount of medication that has been injected.
Who Else Makes It
Concentrated in Zhejiang (3), Shanghai (2), Guangdong (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Promisemed Hangzhou Meditech Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 21 |
| Hangzhou Yunchi Technology Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 19 |
| Shenzhen Yuwen E-Commerce Co., Ltd. | Shenzhen | Guangdong | Repacker / relabeller | 19 |
| Shanghai Chuangshi Medical Technology (Group) Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 14 |
| Changsha Yuhong Trading Co., Ltd. | Changsha | Hunan | Manufacturer | 12 |
| Zhejiang Runlab Technology Co., Ltd. | Taizhou | Zhejiang | Contract manufacturer | 7 |
| Shanghai Huizhou Industrial Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 2 |
Record
| 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 | 2025-12-09 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Over the counter | Yes |
| Label carries | lot or batch number, manufacturing date |
| Storage | Storage environment temperature -10 to 30 °C |
| Packaging | Inner pack of 5, case of 10 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 12002025 | In distribution |
Same Product Code
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.