BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    DxH

    DI: 15099590744830 · Model: C67249 · Beckman Coulter, Inc.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    DxH
    Primary DI
    15099590744830
    Version / Model
    C67249
    Catalog Number
    C67249
    Company Name
    Beckman Coulter, Inc.
    Labeler DUNS
    008254708
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2023-08-04
    Public Version
    1
    Public Version Date
    2023-08-14
    Public Version Status
    New
    Public Device Record Key
    a62c1d8d-ed0b-441b-a4fc-8965d04632ec

    Device Description

    DxH Concentrated ECO Diluent, when diluted to a working concentration, is an osmotically balanced, pH neutral solution of organic buffers, germicides, and sodium/potassium salts. The diluent acts as an electrolyte and cell volume stabilizer for the automated quantitative analysis of red blood cells, platelets, and with the addition of DxH ECO Lytic reagent, the differentiation of leukocytes subpopulations, and hemoglobin measurement.

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    Yes
    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
    Yes
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    GIF Diluent, Blood Cell

    GMDN Terms

    Code Name
    55855 Full blood count IVD, reagent

    Identifiers

    Type ID
    Primary 15099590744830