FDA device listing
Ascensia Contour Blood Glucose Meter, Model 7151;,Reagent Strip;
FDA device listing 1411041255 · RR Donnelley GTS Poland Sp. z o.o.
Key facts
| Proprietary names | Ascensia Contour Blood Glucose Meter, Model 7151;,Reagent Strip; |
|---|---|
| Owner/operator | RR Donnelley GTS Poland Sp. z o.o. |
| Owner/operator number | 10033813 |
| Premarket submissions | K062058 |
| 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 | RR Donnelley GTS Poland Sp. z o.o. |
| Establishment registrations | 3008606429 |
| FEI numbers | 3008606429 |
| Establishment operations | Contract Manufacturer, Foreign Exporter |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- 10–99 UDI devices (GUDID) under the same submission
- 1–9 Device listings citing the same submission
- Yes 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