BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Globe® Platform

    DI: 07540162100338 · Model: 601-00066 · Kardium Inc
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Globe® Platform
    Primary DI
    07540162100338
    Version / Model
    601-00066
    Company Name
    Kardium Inc
    Labeler DUNS
    248480043
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2025-09-15
    Public Version
    1
    Public Version Date
    2025-09-23
    Public Version Status
    New
    Public Device Record Key
    98d30818-d0a7-4b44-895c-6a1a46b0a7ff

    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
    Yes
    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
    QWA Cardiovascular Delivery Catheter System Positioning And Stabilization Device

    GMDN Terms

    Code Name
    63544 Cardiac implantation catheter platform base, single-use

    Identifiers

    Type ID
    Package 07540162100345
    Primary 07540162100338