OneTouch Verio
OneTouch Verio Blood Glucose Test Strips. In vitro Diagnostic. For Self-testing. For blood glucose testing with the OneTouch Verio Family of Meters.For DME Beneficiaries Only
5manufacturers in China registered for this device type
8catalogue numbers in this listing
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 | Lifescan Europe Gmbh, Switzerland |
|---|---|
| FDA product code | LFR |
| Device type | Glucose Dehydrogenase, Glucose |
| Device class | Class 2 |
| Regulation | 21 CFR 862.1345 |
| Establishment | Specification developer, Manufacturer |
| 510(k) | K131363 |
| Record published | 2020-04-12 |
| Record revised | 2026-04-13 (version 8) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Over the counter | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| Storage | Storage environment temperature 41 to 86 °F; Special storage condition: Discard 6 months after opening; Special storage condition: Store your test strips in the vial only |
| Packaging | Shipper case of 450, shipper case of 24, shipper case of 240, shipper case of 32 |
| Distribution end date | 2025-12-04 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 022-978 | 50 | In distribution | |
| 022-899 | 50 | In distribution | |
| 013-046 | 25 | In distribution | |
| 022-270 | 25 | In distribution | |
| 022-898 | 100 | In distribution | |
| 024-174 | 10 | Withdrawn | |
| 011-817 | 10 | Withdrawn | |
| 022-659 | Hematocrit 20 – 60% | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| True Metrix | Trividia Health, Inc. | 15 |
| Contour® | Ascensia Diabetes Care US Inc. | 10 |
| Fora | Fora Care Inc. | 9 |
| Contour® Next ONE | Ascensia Diabetes Care US Inc. | 9 |
| True Metrix GO | Trividia Health, Inc. | 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
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.