BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    SelectaLyte (Potassium Electrode)

    DI: 00850229007331 · Model: 3910 · AWARENESS TECHNOLOGY, INCORPORATED
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    SelectaLyte (Potassium Electrode)
    Primary DI
    00850229007331
    Version / Model
    3910
    Company Name
    AWARENESS TECHNOLOGY, INCORPORATED
    Labeler DUNS
    071065130
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2019-06-26
    Public Version
    1
    Public Version Date
    2019-07-04
    Public Version Status
    New
    Public Device Record Key
    1c45d212-9ba2-4da9-969f-f556fdd65e09

    Device Characteristics

    Single Use
    No
    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
    Yes
    Has Lot/Batch Number
    No
    Has Manufacturing Date
    No
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    CEM Electrode, Ion Specific, Potassium

    GMDN Terms

    Code Name
    52866 Multiple electrolyte IVD, kit, ion-selective electrode (ISE)

    Identifiers

    Type ID
    Primary 00850229007331

    Premarket Submissions

    Submission Number Supplement Number
    K171476 000