BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    RHYTHMIA HDx™

    DI: 08714729938590 · Model: M004RA9000ICM30 · BOSTON SCIENTIFIC CORPORATION
    View on AccessGUDID
    Product Codes
    2
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    RHYTHMIA HDx™
    Primary DI
    08714729938590
    Version / Model
    M004RA9000ICM30
    Company Name
    BOSTON SCIENTIFIC CORPORATION
    Labeler DUNS
    021717889
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2017-05-01
    Public Version
    2
    Public Version Date
    2018-03-29
    Public Version Status
    Update
    Public Device Record Key
    85e3cbe8-5008-458d-b1bc-994a7ee5d7ce

    Device Description

    Clearsign™ Direct Connect IC Orion™

    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
    IKD CABLE, ELECTRODE
    DQK COMPUTER, DIAGNOSTIC, PROGRAMMABLE

    GMDN Terms

    Code Name
    47487 Electrical-only medical device connection cable, reusable

    Identifiers

    Type ID
    Primary 08714729938590