BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    Blackrock NeuroPort Biopotential Signal Processing System

    DI: 00814901020292 · Model: 7.0.2 · BLACKROCK MICROSYSTEMS, LLC
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Blackrock NeuroPort Biopotential Signal Processing System
    Primary DI
    00814901020292
    Version / Model
    7.0.2
    Catalog Number
    RS-0101
    Company Name
    BLACKROCK MICROSYSTEMS, LLC
    Labeler DUNS
    827132015
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2018-09-06
    Public Version
    3
    Public Version Date
    2023-05-19
    Public Version Status
    Update
    Public Device Record Key
    7f495c87-4587-4148-8ae9-332d511d6098
    Distribution End Date
    2023-05-18

    Device Description

    NeuroPort Central Suite

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    No
    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
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    GWL Amplifier, Physiological Signal

    GMDN Terms

    Code Name
    47541 Bioelectrical signal analysis software

    Identifiers

    Type ID
    Primary 00814901020292

    Customer Contacts

    Phone
    +18015825533
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K090957 000