BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    PHOENIX DIAGNOSTICS, INC.

    DI: 00853366007073 · Model: 21-107 · PHOENIX DIAGNOSTICS, INC.
    View on AccessGUDID
    Product Codes
    3
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

    Basic Information

    Brand Name
    PHOENIX DIAGNOSTICS, INC.
    Primary DI
    00853366007073
    Version / Model
    21-107
    Company Name
    PHOENIX DIAGNOSTICS, INC.
    Labeler DUNS
    606814960
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2018-01-25
    Public Version
    4
    Public Version Date
    2020-03-30
    Public Version Status
    Update
    Public Device Record Key
    cd8c79cd-d832-4c3f-b241-6d7e8a1e7f49

    Device Description

    ISE Internal Reference Fill Solution for Olympus AU Series Chemistry Systems

    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
    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
    JGS Electrode, Ion Specific, Sodium
    CEM Electrode, Ion Specific, Potassium
    CGZ Electrode, Ion-Specific, Chloride

    GMDN Terms

    Code Name
    52867 Multiple electrolyte IVD, calibrator

    Identifiers

    Type ID
    Package 10853366007070
    Primary 00853366007073

    Premarket Submissions

    Submission Number Supplement Number
    K020148 000