FDA device listing
ONETOUCH VERIO SYNC BLOOD GLUCOSE MONITORING SYSTEM
FDA device listing 2072027320 · Flextronics International USA, Inc.
Key facts
| Proprietary names | ONETOUCH VERIO SYNC BLOOD GLUCOSE MONITORING SYSTEM |
|---|---|
| Owner/operator | Flextronics International USA, Inc. |
| Owner/operator number | 9006592 |
| Product codes | LFR, NBW |
| Device names | LFR - Glucose Dehydrogenase, Glucose, NBW - System, Test, Blood Glucose, Over The Counter |
| Device class | Class II |
| Classification regulations (21 CFR) | 862.1345 |
| Review panels | Clinical Chemistry |
| Registered establishments | Flextronics Industrial (Shenzhen) Co., Ltd. |
| Establishment registrations | 3007710663 |
| FEI numbers | 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