BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    AUVON

    DI: 06971292001591 · Model: DS-W150100011 · Shenzhen Yuwen E-Commerce Co., Ltd.
    View on AccessGUDID
    Product Codes
    2
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

    Basic Information

    Brand Name
    AUVON
    Primary DI
    06971292001591
    Version / Model
    DS-W150100011
    Company Name
    Shenzhen Yuwen E-Commerce Co., Ltd.
    Labeler DUNS
    544559614
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2023-03-20
    Public Version
    1
    Public Version Date
    2023-03-28
    Public Version Status
    New
    Public Device Record Key
    6af01d24-5cbf-44ee-8893-1218802e5b0d

    Device Description

    The DS-W Blood Glucose Monitoring System is intended for use outside the body (in vitro diagnostic use). It should be used only for testing purposes and only with fresh whole blood samples. It should not be used for the diagnosis of diabetes.

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    No
    Over the Counter (OTC)
    Yes
    Kit
    Yes
    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
    Yes
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    Yes
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    NBW System, Test, Blood Glucose, Over The Counter
    CGA Glucose Oxidase, Glucose

    GMDN Terms

    Code Name
    62537 Glucose monitoring system IVD, home-use

    Identifiers

    Type ID
    Package 16971292001598
    Primary 06971292001591