BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Provizio SEM Scanner S Sensor

    DI: 00860740002630 · Model: 02630 · Bruin Biometrics, LLC
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    3
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Provizio SEM Scanner S Sensor
    Primary DI
    00860740002630
    Version / Model
    02630
    Company Name
    Bruin Biometrics, LLC
    Labeler DUNS
    962732025
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2022-06-28
    Public Version
    2
    Public Version Date
    2024-01-03
    Public Version Status
    Update
    Public Device Record Key
    ff439cbf-1aea-4703-98b9-f328c20e1337

    Device Description

    Provizio SEM Scanner S Sensor - Individual

    Device Characteristics

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

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    QEF Pressure Ulcer Management Tool

    GMDN Terms

    Code Name
    63424 Localized oedema electrical impedance scanner

    Identifiers

    Type ID
    Package 10860740002637
    Primary 00860740002630
    Package 20860740002634

    Premarket Submissions

    Submission Number Supplement Number
    DEN170021 000