BEUDAMED
    FDA Registration Active 🇺🇸 United States

    3B MEDICAL INC

    Reg #: 3042507287 · FEI: 3042507287 · Expires 2026
    View on FDA
    Products
    5
    Proprietary Names
    27
    Establishment Types
    2
    Classifications
    5

    Registration Details

    Registration Name
    3B MEDICAL INC
    Registration Number
    3042507287
    FEI Number
    3042507287
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    1054 Gateway Park Dr
    City
    W Jefferson
    State
    OH
    ZIP
    43162
    Country
    US

    Regulatory Submissions

    510(k) Number
    K131901

    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
    Shalini Yadav

    Products

    Device Name Product Code
    Ventilator, Non-Continuous (Respirator) BZD
    Humidifier, Respiratory Gas, (Direct Patient Interface) BTT
    Generator, Oxygen, Portable CAW
    Ventilator, Continuous, Non-Life-Supporting MNS
    Cannula, Nasal, Oxygen CAT

    Proprietary Names

    Siesta full face mask; Siesta nasal mask (F5A; N5B) iOTM Mini Nasal Mask (Ivolve Nasal Mask, Ivolve Full Face Mask, Ivolve N2) Optiflow Platinum® Mobile Oxygen Concentrator Perfecto2™ Oxygen Concentrator; Platinum® Oxygen Concentrator Numa II Full Face Mask (F4) - (Device Modification) ((Viva Nasal Mask (Model: NM4), Numa Full Face Mask (Model: BMC-FM2) Numa Full Face Mask (BMC-FM2) ((Viva Nasal Mask (Model: NM4), Numa Full Face Mask (Model: BMC-FM2)) F2 Single-Patient Vented Full Face Mask (BMC-FM2) - (Device Modification) ((BMC-NM Nasal Mask, BMC-NM2 Nasal Mask Viva Nasal Mask (Model: NM4) (Viva Nasal Mask (Model: NM4), Numa Full Face Mask (Model: BMC-FM2)) Generator, oxygen, portable PreciseRx™ Pediatric Flowmeter G3 B25VT G3 B30VT Luna G3 APAP Luna G3 CPAP Luna G3 BPAP 25A G3X APAP Noncontinuous Ventilator (IPPB) - Auto CPAP System - M1 Mini Platinum® Mobile Oxygen Concentrator with Connectivity; Mobile Medical Application Accessory; USB Bluetooth Luna G3 BPAP 25/30VT Perfecto2V Oxygen Concentrator Rio II Nasal Pillows Interface (P2) - K112271(Device Modification) – 3B Willow((3B WillowTM Nasal Mask)) Luna II/Auto Luna II CPAP and Auto CPAP System (Luna II QX CPAP and Auto CPAP System) PHOENIX 5 Oxygen Concentrator HomeFill® Oxygen System Phoenix Pulse Portable Oxygen Concentrator

    Establishment Types

    Repack or Relabel Medical Device Manufacture Medical Device