BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Diazyme

    DI: 00817089023048 · Model: DZ122A-KY1 · DIAZYME LABORATORIES, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    Diazyme
    Primary DI
    00817089023048
    Version / Model
    DZ122A-KY1
    Company Name
    DIAZYME LABORATORIES, INC.
    Labeler DUNS
    080507219
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2026-01-21
    Public Version
    1
    Public Version Date
    2026-01-29
    Public Version Status
    New
    Public Device Record Key
    45b938d4-7106-4ca8-8bdb-ae808f5c3687

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    No
    Over the Counter (OTC)
    No
    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
    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
    KHS Enzymatic, Carbon-Dioxide

    GMDN Terms

    Code Name
    60768 Carbon dioxide (CO2) IVD, kit, spectrophotometry

    Identifiers

    Type ID
    Primary 00817089023048

    Premarket Submissions

    Submission Number Supplement Number
    K060619 000