BEUDAMED
    FDA Registration Active 🇺🇸 United States

    VENTEC LIFE SYSTEMS, INC.

    Reg #: 3013095415 · FEI: 3013095415 · Expires 2026
    View on FDA
    Products
    9
    Proprietary Names
    8
    Establishment Types
    4
    Classifications
    9

    Registration Details

    Registration Name
    VENTEC LIFE SYSTEMS, INC.
    Registration Number
    3013095415
    FEI Number
    3013095415
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    22002 26th Ave SE
    City
    Bothell
    State
    WA
    ZIP
    98021
    Country
    US

    Regulatory Submissions

    510(k) Number
    K020386

    Owner / Operator

    Firm Name
    REACT HEALTH
    Operator Number
    10054872
    Address
    22002 26th avenue SE
    City
    Bothell
    State
    WA
    Postal Code
    98021
    Country
    US
    Correspondent
    Shalini Yadav

    Products

    Device Name Product Code
    Generator, Oxygen, Portable CAW
    Cannula, Nasal, Oxygen CAT
    Continuous, Ventilator, Home Use NOU
    Ventilator, Continuous, Facility Use CBK
    Pump, Portable, Aspiration (Manual Or Powered) BTA
    Device, Positive Pressure Breathing, Intermittent NHJ
    Filter, Bacterial, Breathing-Circuit CAH
    Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer BZE
    Humidifier, Respiratory Gas, (Direct Patient Interface) BTT

    Proprietary Names

    Perfecto2™ Oxygen Concentrator; Platinum® Oxygen Concentrator Optiflow VOCSN Platinum® Mobile Oxygen Concentrator PreciseRx™ Pediatric Flowmeter Platinum® Mobile Oxygen Concentrator with Connectivity; Mobile Medical Application Accessory; USB Bluetooth Dongle HomeFill® Oxygen System Perfecto2V Oxygen Concentrator

    Establishment Types

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