Data / Medical devices / Insulin Vial Protector/Holder
Insulin Vial Protector/Holder (OJL): 9 FDA-registered makers in 3 countries
9 establishments in 3 countries are registered with the FDA to make Insulin Vial Protector/Holder (product code OJL, Class 1, 21 CFR 890.5050). 0 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 0 510(k) clearances under this code, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- OJL
- Device class
- 1
- Regulation
- 890.5050
- Medical specialty
- Physical Medicine
Makers by country
| Country | Makers |
|---|---|
| China | 6 |
| United States | 2 |
| Israel | 1 |
Makers of Insulin Vial Protector/Holder
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Ambi, Inc. | Capitola, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Changsha Yuhong Trading Co., Ltd. | Changsha Hunan, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hangzhou Yunchi Technology Co., Ltd | Hangzhou Zhejiang, China | Contract manufacturer, Exporter to the US, Manufacturer, Remanufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Onlycare Inc | Denver, CO, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Promisemed Hangzhou Meditech Co.,ltd. | Hangzhou Zhejiang, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shanghai Huizhou Industrial Co., Ltd | Shanghai City District, China | Contract manufacturer, Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shanghai Chuangshi Medical Technology (Group) Co., Ltd. | Shanghai, China | Contract manufacturer, Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| TempraMed Israel Ltd. | Tel Aviv, Israel | Contract manufacturer, Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zhejiang Runlab Technology Co., Ltd. | Taizhou Zhejiang, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated November 2, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.