BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    VivaGuard Ino Blood Glucose Meter

    DI: 00840423500004 · Model: VGM01-373 · ABOUND Diagnostics, Inc.
    View on AccessGUDID
    Product Codes
    3
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

    Basic Information

    Brand Name
    VivaGuard Ino Blood Glucose Meter
    Primary DI
    00840423500004
    Version / Model
    VGM01-373
    Catalog Number
    VGM01-373
    Company Name
    ABOUND Diagnostics, Inc.
    Labeler DUNS
    119217208
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2025-06-03
    Public Version
    1
    Public Version Date
    2025-06-11
    Public Version Status
    New
    Public Device Record Key
    9df9a110-5cd7-44f8-a739-021e44d85608

    Device Description

    VivaGuard Ino Blood Glucose Meter

    Device Characteristics

    Single Use
    No
    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
    NBW System, Test, Blood Glucose, Over The Counter
    CGA Glucose Oxidase, Glucose
    JJX Single (Specified) Analyte Controls (Assayed And Unassayed)

    GMDN Terms

    Code Name
    62645 Glucose analyser IVD, home-use

    Identifiers

    Type ID
    Primary 00840423500004
    Package 00840423500677