FDA device listing
Freestyle Libre Flash Glucose Monitoring System:PRT22175-135 - ASSY, READER, SYSTEM A, MG/DL, 22175, EN-US/ES-US…
FDA device listing 1208606749 · Flextronics International USA, Inc.
Key facts
| Proprietary names | Freestyle Libre Flash Glucose Monitoring System:PRT22175-135 - ASSY, READER, SYSTEM A, MG/DL, 22175, EN-US/ES-US, GOVT,Freestyle Libre Flash Glucose Monitoring System:PRT22175-137 - ASSY, READER, SYSTEM A, MG/DL, 22175, EN-US/ES-US, GOVT, NFRS,Freestyle Libre Flash Glucose Monitoring System:PRT29000-510 - ASSY, READER, SYSTEM D, MG/DL, 29000, EN-US , GOVT,Freestyle Libre Flash Glucose Monitoring… |
|---|---|
| Owner/operator | Flextronics International USA, Inc. |
| Owner/operator number | 9006592 |
| Product codes | PZE |
| Device names | PZE - Sensor, Glucose, Invasive, Non-Adjunctive, Factory-Calibrated, User-Initiated |
| Device class | Class III |
| Classification regulations (21 CFR) | ORCA1.PZE |
| Review panels | Clinical Chemistry |
| Registered establishments | Flextronics Manufacturing Aguascalientes, S.A de C.V, Flextronics Medical Device Manufacturing (Shenzhen) Co., Ltd. |
| Establishment registrations | 3003600763, 3007421145 |
| FEI numbers | 3003600763, 3004173703 |
| Establishment operations | Contract 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