BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    FORA

    DI: 00816042013256 · Model: D40 · FORA CARE INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    50

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    Basic Information

    Brand Name
    FORA
    Primary DI
    00816042013256
    Version / Model
    D40
    Company Name
    FORA CARE INC.
    Labeler DUNS
    004340807
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    50
    Record Status
    Published
    Publish Date
    2018-07-24
    Public Version
    4
    Public Version Date
    2026-04-13
    Public Version Status
    Update
    Public Device Record Key
    5690d63f-db39-493f-b906-cb6edc4f4b40

    Device Description

    Blood Glucose Test Strips

    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
    CGA Glucose Oxidase, Glucose

    GMDN Terms

    Code Name
    53303 Glucose IVD, kit, electrometry

    Identifiers

    Type ID
    Primary 00816042013256
    Unit of Use 80816042013252

    Premarket Submissions

    Submission Number Supplement Number
    K101926 000