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    FDA UDI In Commercial Distribution 🇺🇸 United States

    PHOENIX DIAGNOSTICS, INC.

    DI: 00853366007585 · Model: 19-006 · PHOENIX DIAGNOSTICS, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    PHOENIX DIAGNOSTICS, INC.
    Primary DI
    00853366007585
    Version / Model
    19-006
    Company Name
    PHOENIX DIAGNOSTICS, INC.
    Labeler DUNS
    606814960
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2018-02-15
    Public Version
    4
    Public Version Date
    2020-03-30
    Public Version Status
    Update
    Public Device Record Key
    0103acbf-e459-4cc2-801c-d4365c017008

    Device Description

    ISE Cal Pack (Snap Pack) for Medica Na/K/Ca/pH EasyLyte Electrolyte 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
    JIX Calibrator, Multi-Analyte Mixture

    GMDN Terms

    Code Name
    52867 Multiple electrolyte IVD, calibrator

    Identifiers

    Type ID
    Primary 00853366007585

    Premarket Submissions

    Submission Number Supplement Number
    K012987 000