BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    PHOENIX DIAGNOSTICS, INC.

    DI: 00853366007264 · Model: 16-221 · 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
    00853366007264
    Version / Model
    16-221
    Company Name
    PHOENIX DIAGNOSTICS, INC.
    Labeler DUNS
    606814960
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2018-01-26
    Public Version
    3
    Public Version Date
    2020-03-30
    Public Version Status
    Update
    Public Device Record Key
    94fe4108-0bff-4175-a6f5-0bed6c6ec1b2

    Device Description

    System Cleaning Solution for Roche / Hitachi 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
    JCB Detergent

    GMDN Terms

    Code Name
    59058 Wash/cleaning solution IVD, automated/semi-automated system

    Identifiers

    Type ID
    Primary 00853366007264