FDA device listing
AUVON, Insulin Cooler Travel Case with Temp Display, model BO2212,AUVON, Insulin Cooler Travel Case with Temp Display…
FDA device listing 1654312216 · UAN HEALTHCARE LIMITED
Key facts
| Proprietary names | AUVON, Insulin Cooler Travel Case with Temp Display, model BO2212,AUVON, Insulin Cooler Travel Case with Temp Display, model BO2222,AUVON, Insulin Cooler with Rechargeable Temp Display, model BO4213,AUVON, Insulin Pen Cooler Travel Case, model BO1120,AUVON, Insulin Pen Cooler Travel Case, model BO1221,AUVON, Insulin Pen Cooler Travel Case, model BO1322,AUVON, Insulin Pen Cooler Travel Case, model… |
|---|---|
| Owner/operator | UAN HEALTHCARE LIMITED |
| Owner/operator number | 10094761 |
| 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 | UAN Healthcare Limited |
| Establishment registrations | 3043013796 |
| FEI numbers | 3043013796 |
| Establishment operations | Foreign Private Label Distributor |
| 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