BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    AVVIGO™ Guidance System II

    DI: 00191506015183 · Model: H749009881I0 · BOSTON SCIENTIFIC CORPORATION
    View on AccessGUDID
    Product Codes
    4
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    AVVIGO™ Guidance System II
    Primary DI
    00191506015183
    Version / Model
    H749009881I0
    Company Name
    BOSTON SCIENTIFIC CORPORATION
    Labeler DUNS
    021717889
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2021-11-17
    Public Version
    1
    Public Version Date
    2021-11-25
    Public Version Status
    New
    Public Device Record Key
    ee3c5908-13ce-42f3-911e-8ddb9b5382bd

    Device Description

    Guidance System

    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
    Labeling does not contain MRI Safety Information
    Direct Marking Exempt
    No
    PM Exempt
    No
    Has Serial Number
    Yes
    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
    DSK COMPUTER, BLOOD-PRESSURE
    DQK Computer, diagnostic, programmable
    IYO System, imaging, pulsed echo, ultrasonic
    ITX Transducer, ultrasonic, diagnostic

    GMDN Terms

    Code Name
    40763 Cardiovascular ultrasound imaging system

    Identifiers

    Type ID
    Primary 00191506015183