BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    VivaGuard Ino

    DI: 00853483008175 · Model: VGC01 · Able Diagnostics Inc
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    VivaGuard Ino
    Primary DI
    00853483008175
    Version / Model
    VGC01
    Catalog Number
    VGC01-373
    Company Name
    Able Diagnostics Inc
    Labeler DUNS
    080952036
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2021-02-03
    Public Version
    3
    Public Version Date
    2026-04-13
    Public Version Status
    Update
    Public Device Record Key
    d6bb3f2d-0339-4f86-b315-dc071204ec2f

    Device Description

    VivaGuard Ino Control Solution 2 (1 bottle/kit)

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    No
    Over the Counter (OTC)
    No
    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
    JJX Single (Specified) Analyte Controls (Assayed And Unassayed)

    GMDN Terms

    Code Name
    53303 Glucose IVD, kit, electrometry

    Identifiers

    Type ID
    Primary 00853483008175