BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    SmartVest

    DI: B102125003S0311 · Model: Clearway Demo · ELECTROMED, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    SmartVest
    Primary DI
    B102125003S0311
    Version / Model
    Clearway Demo
    Catalog Number
    125003-S-031
    Company Name
    ELECTROMED, INC.
    Labeler DUNS
    036514250
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2025-01-21
    Public Version
    1
    Public Version Date
    2025-01-29
    Public Version Status
    New
    Public Device Record Key
    e7ef3bab-76a6-480f-9095-6ff93a6fb261

    Device Description

    Electromed SmartVest Clearway Air Pulse Generator Demo

    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
    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
    BYI Percussor, Powered-Electric

    GMDN Terms

    Code Name
    38123 Chest-oscillation airway secretion-clearing system generator

    Identifiers

    Type ID
    Primary B102125003S0311