BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    CARBON DIOXIDE L3K-C Assay

    DI: 00628063400331 · Model: 288-36 · SEKISUI DIAGNOSTICS, LLC
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    3

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    Basic Information

    Brand Name
    CARBON DIOXIDE L3K-C Assay
    Primary DI
    00628063400331
    Version / Model
    288-36
    Catalog Number
    288-36
    Company Name
    SEKISUI DIAGNOSTICS, LLC
    Labeler DUNS
    966812344
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    3
    Record Status
    Published
    Publish Date
    2016-09-16
    Public Version
    4
    Public Version Date
    2023-07-06
    Public Version Status
    Update
    Public Device Record Key
    44271861-3382-492a-ac11-01d439814235

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    Yes
    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 00628063400331
    Unit of Use 10628063400338

    Premarket Submissions

    Submission Number Supplement Number
    K002354 000