BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    MicroScan

    DI: 15099590658007 · Model: B1017-425 · Beckman Coulter, Inc.
    View on AccessGUDID
    Product Codes
    4
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    20

    Basic Information

    Brand Name
    MicroScan
    Primary DI
    15099590658007
    Version / Model
    B1017-425
    Company Name
    Beckman Coulter, Inc.
    Labeler DUNS
    008254708
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    20
    Record Status
    Published
    Publish Date
    2016-08-24
    Public Version
    4
    Public Version Date
    2023-11-10
    Public Version Status
    Update
    Public Device Record Key
    fc4e55dd-0e6d-4e86-8d76-f440e6a860de

    Device Description

    Neg MIC Panel Type 46

    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
    LTW Susceptibility Test Cards, Antimicrobial
    LRG Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems
    JWY Manual Antimicrobial Susceptibility Test Systems
    LTT Panels, Test, Susceptibility, Antimicrobial

    GMDN Terms

    Code Name
    58605 General-microorganism antimicrobial susceptibility culture medium IVD

    Identifiers

    Type ID
    Primary 15099590658007
    Unit of Use 05099590658000

    Premarket Submissions

    Submission Number Supplement Number
    K010418 000
    K032706 000
    K050585 000
    K061536 000
    K083262 000
    K101425 000
    K192355 000
    K201423 000
    K202343 000
    K862140 000
    K863776 000
    K870074 000
    K874876 000
    K883076 000
    K926545 000
    K941030 000
    K955910 000
    K962150 000
    K970676 000
    K971376 000
    K981199 000