Contour®
Blood Glucose Monitoring System. 1 kit. For self-monitoring and management of blood glucose. In this kit you will find: CONTOUR® Blood Glucose Meter; 10 Blood Glucose Test Strips; Normal…
Blood Glucose Monitoring System. 1 kit. For self-monitoring and management of blood glucose. In this kit you will find: CONTOUR® Blood Glucose Meter; 10 Blood Glucose Test Strips; Normal Control Solution; Quick Reference Guide; User Guide; Lancing Device; 10 Lancets (provided sterile); Logbook; Carrying Case; Warranty Card.
Who Else Makes It
Concentrated in Tianjin (2), Guangdong (2), Jiangsu (1). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Andon Health Co., Ltd. | Tianjin | Tianjin | Contract manufacturer | 22 |
| Flextronics Medical Device Manufacturing (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 6 |
| Flextronics Industrial (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 5 |
| Jiangsu NEW Pentastar Medical Products Co., Ltd. | Changzhou | Jiangsu | Exporter | 146 |
| Tianjin Empecs Medical Device Co., Ltd. | Tianjin | Tianjin | Contract manufacturer | 8 |
Record
| Listed by | Ascensia Diabetes Care US Inc., United States |
|---|---|
| FDA product code | LFR |
| Device type | Glucose Dehydrogenase, Glucose |
| Device class | Class 2 |
| Regulation | 21 CFR 862.1345 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K062058 |
| Record published | 2016-09-16 |
| Record revised | 2026-05-13 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Over the counter | Yes |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date, serial number |
| Storage | Storage environment temperature 59 to 86 °F |
| Packaging | Shipper/case of 24, carton, shipper/case of 4, shipper/case of 12, shipper / speed pack of 4, carton of 2 |
| Distribution end date | 2024-04-23 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 9556C | In distribution | ||
| 7098C | 50 | In distribution | |
| 7080G | 50 | In distribution | |
| 7151H | Withdrawn | ||
| 7189 | Withdrawn | ||
| 7070A | 25 | Withdrawn | |
| 7099C | 50 | Withdrawn | |
| 9545C | Withdrawn | ||
| 9507C | 10 | Withdrawn | |
| 7097C | 50 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| True Metrix | Trividia Health, Inc. | 15 |
| Fora | Fora Care Inc. | 9 |
| Contour® Next ONE | Ascensia Diabetes Care US Inc. | 9 |
| True Metrix GO | Trividia Health, Inc. | 8 |
| OneTouch Verio | Lifescan Europe Gmbh | 8 |
| Accu-Chek Aviva Plus | Roche Diagnostics Operations | 7 |
| McKesson | Mckesson Medical-Surgical Inc. | 7 |
| Accu-Chek Guide | Roche Diagnostics Operations | 7 |
| Contour® Next | Ascensia Diabetes Care US Inc. | 6 |
| Accu-Chek Smart View | Roche Diagnostics Operations | 6 |
| FreeStyle Lite | Abbott Diabetes Care Limited | 5 |
| Precision Xtra | Abbott Diabetes Care Limited | 5 |
Showing 12 of 124. All products under Glucose Dehydrogenase, Glucose
Recalls Naming This Product
2 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Bayer HealthCare, LLC | 510(k) number | 2011-08-12 | Not classified | Packaging | All 10- or 25- count glucose test strip vials, either loose vials or found in patient starter kits of Contour, Contour TS and Contour” USB blood glucose meters are being recalled a packaging issue which, under certain conditions, can cause | 3,617,287 vials/ 54,555,460 test strips | 2012-07-02 |
| Bayer HealthCare, LLC | 510(k) number | 2007-06-06 | Not classified | Other | Incorrect Unit of Measure displayed : The meters report results in the wrong unit of measurement for Canadian users. | 16-Canadian Units only are affected | 2007-11-30 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.