BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    iQ®200

    DI: 10837461002192 · Model: iQ® Lamina™ Cradle · IRIS INTERNATIONAL, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    iQ®200
    Primary DI
    10837461002192
    Version / Model
    iQ® Lamina™ Cradle
    Catalog Number
    800-3105
    Company Name
    IRIS INTERNATIONAL, INC.
    Labeler DUNS
    098240690
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-09-07
    Public Version
    4
    Public Version Date
    2023-09-08
    Public Version Status
    Update
    Public Device Record Key
    284bdd6c-d8c6-435f-bcee-70463f135cdd
    Distribution End Date
    2023-06-30

    Device Description

    iQ® Lamina™ Cradle

    Device Characteristics

    Single Use
    Yes
    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
    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
    LKM Counter, Urine Particle

    GMDN Terms

    Code Name
    35918 Urine analyser IVD, laboratory

    Identifiers

    Type ID
    Primary 10837461002192