FDA device listing
Insulin Cooler Travel Case with Temp Display, model BO2212, BO2222,Insulin Cooler with Rechargeable Temp Display, model…
FDA device listing 1955319598 · Changsha Yuhong Trading Co., Ltd.
Key facts
| Proprietary names | Insulin Cooler Travel Case with Temp Display, model BO2212, BO2222,Insulin Cooler with Rechargeable Temp Display, model BO4213,Insulin Pen Cooler Travel Case, model BO1120,Insulin Pen Cooler Travel Case, model BO1221,Insulin Pen Cooler Travel Case, model BO1341,Insulin Pen Cooler Travel Case, model BO2120,Insulin Pen Cooler Travel Case, model BO3213,Insulin Pen Cooler Travel Case, model… |
|---|---|
| Owner/operator | Changsha Yuhong Trading Co., Ltd. |
| Owner/operator number | 10093902 |
| Product codes | OJL |
| Device names | OJL - Insulin Vial Protector/Holder |
| Device class | Class I |
| Classification regulations (21 CFR) | 890.5050 |
| Review panels | Physical Medicine |
| Registered establishments | CHANGSHA YUHONG TRADING CO., LTD. |
| Establishment registrations | 3040389283 |
| FEI numbers | 3040389283 |
| Establishment operations | Manufacturer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- None listed Premarket submission listed
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device listings
Establishments that make or process devices for the U.S. market must list each device with the FDA. A listing records the device's proprietary names, product codes and premarket submission, and every registered establishment that handles it.
Source: U.S. Food and Drug Administration (FDA), Establishment Registration and Device Listing database