BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    INVIVE™

    DI: 00802526536625 · Model: V172 · BOSTON SCIENTIFIC CORPORATION
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    INVIVE™
    Primary DI
    00802526536625
    Version / Model
    V172
    Company Name
    BOSTON SCIENTIFIC CORPORATION
    Labeler DUNS
    106295384
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2014-09-24
    Public Version
    4
    Public Version Date
    2018-12-11
    Public Version Status
    Update
    Public Device Record Key
    03bd79ea-812f-4352-a899-df6151f95c24

    Device Description

    Cardiac Resynchronization Therapy Pacemaker

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

    Sterilization

    Is Sterile
    Yes
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    NKE Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)

    GMDN Terms

    Code Name
    31704 Cardiac pulse generator test magnet

    Identifiers

    Type ID
    Primary 00802526536625

    Premarket Submissions

    Submission Number Supplement Number
    P030005 099
    P030005 106
    P030005 107
    P030005 113
    P030005 116
    P030005 138
    P030005 176