BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    PHOENIX DIAGNOSTICS, INC.

    DI: 00853366007066 · Model: 21-106 · PHOENIX DIAGNOSTICS, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

    Basic Information

    Brand Name
    PHOENIX DIAGNOSTICS, INC.
    Primary DI
    00853366007066
    Version / Model
    21-106
    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
    3
    Public Version Date
    2020-03-30
    Public Version Status
    Update
    Public Device Record Key
    5f242a53-fa7b-46d0-863d-012ad5a48d88

    Device Description

    ISE Low/High Urine Standard 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
    Yes
    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
    Package 10853366007063
    Primary 00853366007066