BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    COULTER LH Series Retic Pak Reagent Kit

    DI: 15099590250973 · Model: 8547196 · Beckman Coulter, Inc.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    COULTER LH Series Retic Pak Reagent Kit
    Primary DI
    15099590250973
    Version / Model
    8547196
    Catalog Number
    8547196
    Company Name
    Beckman Coulter, Inc.
    Labeler DUNS
    008254708
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2020-08-31
    Public Version
    1
    Public Version Date
    2020-09-08
    Public Version Status
    New
    Public Device Record Key
    d9b45c2b-a961-4f60-a016-d1605884c18d

    Device Description

    COULTER LH Series Retic Pak Reagent Kit

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    Yes
    Over the Counter (OTC)
    No
    Kit
    Yes
    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
    GGK Products, Red-Cell Lysing Products

    GMDN Terms

    Code Name
    55863 Reticulocyte count IVD, reagent

    Identifiers

    Type ID
    Primary 15099590250973

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    2 – 30 Degrees Celsius