BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Ventis Medical Inc

    Reg #: 3021607937 · FEI: 3021607937 · Expires 2026
    View on FDA
    Products
    2
    Proprietary Names
    3
    Establishment Types
    3
    Classifications
    2

    Registration Details

    Registration Name
    Ventis Medical Inc
    Registration Number
    3021607937
    FEI Number
    3021607937
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    515 Executive Dr
    City
    Princeton
    State
    NJ
    ZIP
    08540
    Country
    US

    Regulatory Submissions

    510(k) Number
    K240807

    Owner / Operator

    Firm Name
    Ventis Medical Inc.
    Operator Number
    10091988
    Address
    2 Stout Rd
    City
    Princeton
    State
    NJ
    Postal Code
    08540
    Country
    US
    Correspondent
    Karen Laub

    Products

    Device Name Product Code
    Connector, Airway (Extension) BZA
    Ventilator, Continuous, Facility Use CBK

    Proprietary Names

    VM-531UEN OXYGEN ENRICHMENT KIT Herovent VM2000 Emergency and Transport Ventilator

    Establishment Types

    Manufacture Medical Device Complaint File Establishment per 21 CFR 820.198 Develop Specifications But Do Not Manufacture At This Facility