BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    MicroScan

    DI: 15099590738884 · Model: V5.00 · Beckman Coulter, Inc.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

    Basic Information

    Brand Name
    MicroScan
    Primary DI
    15099590738884
    Version / Model
    V5.00
    Catalog Number
    C62574
    Company Name
    Beckman Coulter, Inc.
    Labeler DUNS
    008254708
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2020-10-23
    Public Version
    2
    Public Version Date
    2022-09-16
    Public Version Status
    Update
    Public Device Record Key
    7795f1a4-2e94-47c4-b8af-98808f41ecab

    Device Description

    DVD, LabPro V5.00 Data Delivery-01 (US, FMR)

    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
    No
    Has Serial Number
    No
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    Yes
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    LON System, Test, Automated, Antimicrobial Susceptibility, Short Incubation

    GMDN Terms

    Code Name
    56747 Microorganism identification/antimicrobial-susceptibility analyser IVD

    Identifiers

    Type ID
    Primary 15099590738884
    Package 15099590738891

    Premarket Submissions

    Submission Number Supplement Number
    K201405 000