BEUDAMED
    FDA Registration Active 🇺🇸 United States

    PreciseRx™ Pediatric Flowmeter

    Reg #: 3013095415 · FEI: 3013095415 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    VENTEC LIFE SYSTEMS, INC.
    Registration Number
    3013095415
    FEI Number
    3013095415
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    22002 26th Ave SE
    City
    Bothell
    State
    WA
    ZIP
    98021
    Country
    US

    Regulatory Submissions

    510(k) Number
    K914488

    Owner / Operator

    Firm Name
    REACT HEALTH
    Operator Number
    10054872
    Address
    5475 Rings Rd, Suite 550
    City
    Dublin
    State
    OH
    Postal Code
    43017
    Country
    US
    Correspondent
    Tina Quintero

    Products

    Device Name Product Code
    Generator, Oxygen, Portable CAW

    Proprietary Names

    PreciseRx™ Pediatric Flowmeter

    Establishment Types

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