BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    LABSYSTEM™ PRO

    DI: 08714729884941 · Model: M00420020230 · BOSTON SCIENTIFIC CORPORATION
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    LABSYSTEM™ PRO
    Primary DI
    08714729884941
    Version / Model
    M00420020230
    Catalog Number
    M00420020220
    Company Name
    BOSTON SCIENTIFIC CORPORATION
    Labeler DUNS
    021717889
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-09-24
    Public Version
    3
    Public Version Date
    2019-12-12
    Public Version Status
    Update
    Public Device Record Key
    726553d7-ae35-43d9-8271-7e9133cae535

    Device Description

    CLEARSIGN™ II Amplifier For LABSYSTEM™ PRO EP Recording System, 120 Channels

    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
    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
    DRQ AMPLIFIER AND SIGNAL CONDITIONER, TRANSDUCER SIGNAL

    GMDN Terms

    Code Name
    32521 Multiple physiological signal amplifier

    Identifiers

    Type ID
    Primary 08714729884941