BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    myLUX™ Patient Kit with mobile device

    DI: 00802526607363 · Model: 666259-100 · BOSTON SCIENTIFIC CORPORATION
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    myLUX™ Patient Kit with mobile device
    Primary DI
    00802526607363
    Version / Model
    666259-100
    Catalog Number
    666259-100
    Company Name
    BOSTON SCIENTIFIC CORPORATION
    Labeler DUNS
    106295384
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2020-07-01
    Public Version
    1
    Public Version Date
    2020-07-09
    Public Version Status
    New
    Public Device Record Key
    228d4525-8848-4eba-9b40-d5f9ee900a3f

    Device Description

    MyLUX(TM) Patient Kit with mobile device

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    Yes
    Over the Counter (OTC)
    No
    Kit
    Yes
    Combination Product
    No
    HCT/P
    No
    Contains NRL
    No
    Not Made with NRL
    No
    MRI Safety
    MR Unsafe
    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
    MXD Recorder, event, implantable cardiac, (with arrhythmia detection)

    GMDN Terms

    Code Name
    61680 Implantable cardiac device management application software

    Identifiers

    Type ID
    Primary 00802526607363

    Premarket Submissions

    Submission Number Supplement Number
    K193473 000