FDA device listing
Insulet5490 (NR) - Omnipod DASH Insulin Management System,Insulet5490 (NR) - OmniPod Insulin Management System
FDA device listing 1610201867 · STERIS Corporation
Key facts
| Proprietary names | Insulet5490 (NR) - Omnipod DASH Insulin Management System,Insulet5490 (NR) - OmniPod Insulin Management System |
|---|---|
| Owner/operator | STERIS Corporation |
| Owner/operator number | 1527821 |
| Product codes | LZG, NBW, NDC |
| Device names | LZG - Pump, Infusion, Insulin, NBW - System, Test, Blood Glucose, Over The Counter, NDC - Calculator, Drug Dose |
| Device class | Class II |
| Classification regulations (21 CFR) | 862.1345, 868.1890, 880.5725 |
| Review panels | Anesthesiology, Clinical Chemistry, General Hospital |
| Registered establishments | ISOMEDIX OPERATIONS INC. |
| Establishment registrations | 1220477 |
| FEI numbers | 1220477 |
| Establishment operations | Contract Sterilizer |
| 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