BEUDAMED
    FDA Registration Active 🇺🇸 United States

    SealFlex

    Reg #: 1832562 · FEI: 1832562 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    4
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Pulmodyne Inc.
    Registration Number
    1832562
    FEI Number
    1832562
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    2055 Executive Dr
    City
    Indianapolis
    State
    IN
    ZIP
    46241
    Country
    US

    Regulatory Submissions

    510(k) Number
    K972605

    Owner / Operator

    Firm Name
    ENGINEERED MEDICAL SYSTEMS
    Operator Number
    9022693
    Address
    2055 EXECUTIVE DR., --
    City
    INDIANAPOLIS
    State
    IN
    Postal Code
    46241
    Country
    US
    Correspondent
    TAMARA - LEFEVERS

    Products

    Device Name Product Code
    Ventilator, Non-Continuous (Respirator) BZD

    Proprietary Names

    SealFlex BiTrac HC BiTrac BiTrac Select

    Establishment Types

    Manufacture Medical Device