BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    AU

    DI: 15099590011925 · Model: OSR61205 · Beckman Coulter, Inc.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    AU
    Primary DI
    15099590011925
    Version / Model
    OSR61205
    Company Name
    Beckman Coulter, Inc.
    Labeler DUNS
    008254708
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-09-24
    Public Version
    3
    Public Version Date
    2018-07-06
    Public Version Status
    Update
    Public Device Record Key
    b9f54f90-2777-49eb-8c2b-f104813d9f73

    Device Description

    UIBC

    Device Characteristics

    Single Use
    Yes
    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
    No
    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
    JMO Ferrozine (Colorimetric) Iron Binding Capacity

    GMDN Terms

    Code Name
    58196 Unsaturated iron binding capacity (UIBC) IVD, kit, spectrophotometry

    Identifiers

    Type ID
    Primary 15099590011925

    Premarket Submissions

    Submission Number Supplement Number
    K041793 000