AUVON
Basic Information
- Brand Name
- AUVON
- Primary DI
- 00850080988060
- Version / Model
- DS-W
- Company Name
- UAN HEALTHCARE LIMITED
- Labeler DUNS
- 765349382
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 75
- Record Status
- Published
- Publish Date
- 2026-02-06
- Public Version
- 1
- Public Version Date
- 2026-02-16
- Public Version Status
- New
- Public Device Record Key
- 7b9c5756-5595-4b65-b2fe-0dd20c4480e4
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.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| CGA | Glucose Oxidase, Glucose | Clinical Chemistry | 862.1345 | 2 |
| NBW | System, Test, Blood Glucose, Over The Counter | Clinical Chemistry | 862.1345 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62537 | 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 00850080988077 | GS1 | 2 | In Commercial Distribution | ||
| Primary | 00850080988060 | GS1 | ||||
| Package | 00850080988084 | GS1 | 4 | In Commercial Distribution | ||
| Unit of Use | 10850080988067 | GS1 |
Customer Contacts
- Phone
- +1(678)829-7256
- [email protected]