BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    iQ®200

    DI: 10837461002345 · Model: iQ® Body Fluids Controls-Level I and Level II (NA/INTL) · BECKMAN COULTER IRELAND INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    iQ®200
    Primary DI
    10837461002345
    Version / Model
    iQ® Body Fluids Controls-Level I and Level II (NA/INTL)
    Catalog Number
    800-3219
    Company Name
    BECKMAN COULTER IRELAND INC.
    Labeler DUNS
    985071975
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-09-07
    Public Version
    4
    Public Version Date
    2023-10-13
    Public Version Status
    Update
    Public Device Record Key
    2bd7780f-f227-40ed-9796-468823acef9d

    Device Description

    iQ® Body Fluids Controls-Level I and Level II (NA/INTL)

    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
    No
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    JPK Mixture, Hematology Quality Control

    GMDN Terms

    Code Name
    42064 Urine sediment IVD, calibrator

    Identifiers

    Type ID
    Primary 10837461002345

    Premarket Submissions

    Submission Number Supplement Number
    K051706 000