BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Noncontinuous Ventilator (IPPB) - Auto CPAP System - M1 Mini

    Reg #: 3009096682 · FEI: 3009096682 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    3B Medical Inc
    Registration Number
    3009096682
    FEI Number
    3009096682
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    5475 Rings Road, Suite 550
    City
    Dublin
    State
    OH
    ZIP
    43017
    Country
    US

    Regulatory Submissions

    510(k) Number
    K211155

    Owner / Operator

    Firm Name
    React Health
    Operator Number
    10040143
    Address
    5475 Rings Road, Suite 550
    City
    Dublin
    State
    OH
    Postal Code
    43017
    Country
    US
    Correspondent
    Margaret Mangano

    Products

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

    Proprietary Names

    Noncontinuous Ventilator (IPPB) - Auto CPAP System - M1 Mini

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198