FDA device listing
MMT-5001A18 MiniMed Duo,MMT-5001A23 MiniMed Duo,MMT-5001A32 MiniMed Duo,MMT-5001A43 MiniMed Duo,MMT-5001B18 MiniMed…
FDA device listing 1637478646 · Medtronic
Key facts
| Proprietary names | MMT-5001A18 MiniMed Duo,MMT-5001A23 MiniMed Duo,MMT-5001A32 MiniMed Duo,MMT-5001A43 MiniMed Duo,MMT-5001B18 MiniMed Duo,MMT-5001B23 MiniMed Duo,MMT-5001B32 MiniMed Duo,MMT-5001B43 MiniMed Duo,MMT-5011A18 MiniMed Duo,MMT-5011A23 MiniMed Duo,MMT-5011A32 MiniMed Duo,MMT-5011A43 MiniMed Duo,MMT-5011B18 MiniMed Duo,MMT-5011B23 MiniMed Duo,MMT-5011B32 MiniMed Duo,MMT-5011B43 MiniMed Duo |
|---|---|
| Owner/operator | Medtronic |
| Owner/operator number | 10094334 |
| Product codes | CGA |
| Device names | CGA - Glucose Oxidase, Glucose |
| Device class | Class II |
| Classification regulations (21 CFR) | 862.1345 |
| Review panels | Clinical Chemistry |
| Registered establishments | MEDTRONIC MINIMED |
| Establishment registrations | 2032227 |
| FEI numbers | 3003166194 |
| Establishment operations | U.S. Manufacturer of Export Only Devices |
| 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