AUVON
- Primary DI
- 00850080988077
- Brand
- AUVON
- Company
- UAN HEALTHCARE LIMITED
- Model
- DS-W
- Device description
- The AUVON DS-W Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm or palm. The AUVON DS-W Blood Glucose Monitoring System is intended to be used by a single person and should not be shared. The AUVON DS-W Blood Glucose Monitoring System is intended for self testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The AUVON DS-W Blood Glucose Monitoring System should not be used for the diagnosis of or screening of diabetes or for neonatal use. Alternative site testing should be done only during steady-state times (when glucose is not changing rapidly). The AUVON DS-W Draw-in Blood Glucose Test Strips are for use with the AUVON DS-W Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm or palm.
- Published
- 2026-02-06
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- false
- OTC
- true
- Sterile
- false
- Single use
- true
Related Records
Contact Domains
Product Codes
| Code | Name |
|---|---|
| CGA | Glucose Oxidase, Glucose |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|---|---|---|
| CGA | Glucose Oxidase, Glucose | Clinical Chemistry | 2 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 00850080988077 | Package | GS1 | 2 | In Commercial Distribution |
| 00850080988084 | Package | GS1 | 4 | In Commercial Distribution |
| 00850080988060 | Primary | GS1 | 0 | |
| 10850080988067 | Unit of Use | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|---|---|---|
| 00850080988077 | 00850080988077 | 850080988077 | 0850080988077 |
| 00850080988084 | 00850080988084 | 850080988084 | 0850080988084 |
| 00850080988060 | 00850080988060 | 850080988060 | 0850080988060 |
| 10850080988067 | 10850080988067 |
GMDN Terms
| Term | Definition |
|---|---|
| Glucose monitoring system IVD, home-use | A collection of devices including a portable, battery-powered, semi-automated or automated instrument (self-testing meter), reagents, test strips and/or other associated materials and accessories (e.g., control solutions, lancets) intended to be used for the quantitative measurement of glucose in a whole blood clinical specimen; it is designed to be used for self-testing by a layperson in the home, and some types may in addition be used at the point-of-care. Measured glucose values are used to manage blood glucose levels, primarily by persons with diabetes mellitus. |
Sterilization Methods
| Method |
|---|
Contacts
| Phone | |
|---|---|
| +1(678)829-7256 | support@iauvon.com |
Regulatory Flags
- DUNS number
- 765349382
- Device count
- 75
- DM exempt
- false
- Premarket exempt
- false
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- true
- Serial number
- false
- Manufacturing date on label
- false
- Expiration date on label
- true
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- false
Other Devices From This Company
| Primary DI | Brand | Model | Catalog | Published |
|---|---|---|---|---|
| 00850080988466 | AUVON | TA2224 | 2026-05-24 | |
| 10850080988142 | AUVON | TX6224 | 2026-03-23 | |
| 10850080988135 | AUVON | TP2408C | 2026-03-19 | |
| 00850080988107 | AUVON | DS-W | 2026-03-02 | |
| 00850080988114 | AUVON | DS-W | 2026-03-02 | |
| 00850080988121 | AUVON | EB1548 | 2026-03-02 | |
| 00850080988046 | AUVON | DS-W | 2026-02-06 | |
| 00850080988091 | AUVON | DS-W | 2026-02-06 |
Other Devices Sharing Product Codes
| Primary DI | Brand | Company | Product code | Published |
|---|---|---|---|---|
| 00850080988107 | AUVON | UAN HEALTHCARE LIMITED | CGA | 2026-03-02 |
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| 00810079240609 | Teladoc Health, Inc. | Teladoc Health, Inc. | CGA | 2026-02-17 |
| 00850080988046 | AUVON | UAN HEALTHCARE LIMITED | CGA | 2026-02-06 |
| MHC1101665140 | EasyTouch | MHC MEDICAL PRODUCTS, LLC | CGA | 2026-01-07 |
| MHC18073000 | EasyTouch | MHC MEDICAL PRODUCTS, LLC | CGA | 2026-01-07 |
| 00810079240432 | Teladoc Health, Inc. | Teladoc Health, Inc. | CGA | 2025-09-25 |
| 10311917064632 | Walgreens | WALGREEN CO. | CGA | 2025-06-20 |
| 00840423500684 | VivaGuard Ino Blood Glucose Test Strips | ABOUND Diagnostics, Inc. | CGA | 2025-06-06 |
| 10673486013580 | Teco Diagnostics TC Matrix Clinical Chemistry Analyzer | TECO DIAGNOSTICS | CGA | 2025-05-28 |
| 10673486013726 | Teco Diagnostics TC Matrix Clinical Chemistry Analyzer | TECO DIAGNOSTICS | CGA | 2025-05-28 |
| 10673486013894 | Teco Diagnostics TC Matrix Clinical Chemistry Analyzer | TECO DIAGNOSTICS | CGA | 2025-05-28 |
| 10673486013962 | Teco Diagnostics TC Matrix Clinical Chemistry Analyzer | TECO DIAGNOSTICS | CGA | 2025-05-28 |
| 16971292003400 | AUVON | Shenzhen Yuwen E-Commerce Co., Ltd. | CGA | 2025-03-14 |
| 16971292003417 | AUVON | Shenzhen Yuwen E-Commerce Co., Ltd. | CGA | 2025-03-14 |
| 00198715270303 | Pro Comfort Blood Glucose Monitor Kit | Care Living Diagnostics Inc. | CGA | 2025-02-25 |
| 10194346219251 | ReliOn™ Premier Blood Glucose Test Strips | WAL-MART STORES, INC. | CGA | 2025-02-11 |
| 10194346219268 | ReliOn™ Premier Blood Glucose Test Strips | WAL-MART STORES, INC. | CGA | 2025-02-11 |
| 10673486000726 | Teco Diagnostics Glucopad Blood Glucose Test Strips | TECO DIAGNOSTICS | CGA | 2024-12-19 |
| 16971292003134 | AUVON | Shenzhen Yuwen E-Commerce Co., Ltd. | CGA | 2024-11-22 |
| 16971292003141 | AUVON | Shenzhen Yuwen E-Commerce Co., Ltd. | CGA | 2024-11-22 |
| 16971292003158 | AUVON | Shenzhen Yuwen E-Commerce Co., Ltd. | CGA | 2024-11-22 |
| 16971292003165 | AUVON | Shenzhen Yuwen E-Commerce Co., Ltd. | CGA | 2024-11-22 |
| 16971292003172 | AUVON | Shenzhen Yuwen E-Commerce Co., Ltd. | CGA | 2024-11-22 |
| 16971292003189 | AUVON | Shenzhen Yuwen E-Commerce Co., Ltd. | CGA | 2024-11-22 |
| 16971292003196 | AUVON | Shenzhen Yuwen E-Commerce Co., Ltd. | CGA | 2024-11-22 |
| 16971292003226 | AUVON | Shenzhen Yuwen E-Commerce Co., Ltd. | CGA | 2024-11-22 |
| 16971292006951 | AUVON | Shenzhen Yuwen E-Commerce Co., Ltd. | CGA | 2024-08-14 |
| 16971292006968 | AUVON | Shenzhen Yuwen E-Commerce Co., Ltd. | CGA | 2024-08-14 |
| 16971292006975 | AUVON | Shenzhen Yuwen E-Commerce Co., Ltd. | CGA | 2024-08-14 |