BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    EKOS™

    DI: 00191506013738 · Model: 600-40500H-AH · BOSTON SCIENTIFIC CORPORATION
    View on AccessGUDID
    Product Codes
    2
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    EKOS™
    Primary DI
    00191506013738
    Version / Model
    600-40500H-AH
    Catalog Number
    600-40500H-AH
    Company Name
    BOSTON SCIENTIFIC CORPORATION
    Labeler DUNS
    021717889
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2023-05-10
    Public Version
    1
    Public Version Date
    2023-05-18
    Public Version Status
    New
    Public Device Record Key
    989e0457-0151-4a30-93f6-1abf72f46c1e

    Device Description

    Console

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

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    QEY Mechanical thrombolysis catheter
    KRA Catheter, continuous flush

    GMDN Terms

    Code Name
    59025 Ultrasound thrombolysis system control unit

    Identifiers

    Type ID
    Primary 00191506013738