Contour Next EZ Blood Glucose Meter
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K130265 FDA 510(k)
- FDA Product Code
- NBW FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 862.1345 FDA 510(k)
- Regulation Number
- 862.1345 FDA 510(k)
- Advisory Committee
- Clinical Chemistry FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Contour Next EZ Blood Glucose Meter is a device designed for self-testing by people with diabetes and by healthcare professionals to monitor glucose concentrations in capillary or venous whole blood. It features Second-Chance Sampling, a large, easy-to-read display, and requires no coding for simplicity and accuracy.
This meter is powered by two standard blood glucose meter batteries and is intended for self-testing in various settings. The device is supplied as a blood glucose monitoring system and is regulated under FDA 510K clearance with product code NBW. It is designed for single-use and requires proper storage to maintain functionality.
Frequently asked questions
What is the Contour Next EZ Blood Glucose Meter used for?
The Contour Next EZ Blood Glucose Meter is designed for self-testing by people with diabetes and by healthcare professionals to monitor glucose concentrations in capillary or venous whole blood.
How is the Contour Next EZ Blood Glucose Meter supplied?
The device is supplied as a blood glucose monitoring system and is powered by two standard blood glucose meter batteries, intended for self-testing in various settings.
Is the Contour Next EZ Blood Glucose Meter single-use or reusable?
The Contour Next EZ Blood Glucose Meter is designed for single-use and requires proper storage to maintain functionality.
What are the key features of the Contour Next EZ Blood Glucose Meter?
The meter features Second-Chance Sampling, a large, easy-to-read display, and requires no coding for simplicity and accuracy in glucose monitoring.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Blutzuckermessgerät | CONTOUR®NEXT, Glucometer: Blood Glucose Monitoring System | CONTOUR®NEXT EZ, Bayer HealthCare Contour next EZ Manual | ManualsLib, BAYER HEALTHCARE CONTOUR NEXT USER MANUAL Pdf Download
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K130265 | Class II | Active |
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Manufacturer
- Manufacturer
- Bayer HealthCare, LLC
Sources (1)
- FDA 510(k) K130265 24 fields · synced Sep 26, 2026