FDA device listing
Omnipod 5 Pod
FDA device listing 1840213319 · INSULET CORPORATION
Key facts
| Proprietary names | Omnipod 5 Pod |
|---|---|
| Owner/operator | INSULET CORPORATION |
| Owner/operator number | 9056196 |
| Product codes | QFG |
| Device names | QFG - Alternate Controller Enabled Insulin Infusion Pump |
| Device class | Class II |
| Classification regulations (21 CFR) | 880.5730 |
| Review panels | Clinical Chemistry |
| Registered establishments | Insulet Corporation, Insulet Malaysia Sdn. Bhd. |
| Establishment registrations | 3014585508, 3030970576 |
| FEI numbers | 3014585508, 3030970576 |
| Establishment operations | Contract Manufacturer, Specification Developer |
| 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