BEUDAMED
    FDA Registration Active 🇺🇸 United States

    3B Medical Inc

    Reg #: 3009096682 · FEI: 3009096682 · Expires 2026
    View on FDA
    Products
    4
    Proprietary Names
    29
    Establishment Types
    3
    Classifications
    4

    Registration Details

    Registration Name
    3B Medical Inc
    Registration Number
    3009096682
    FEI Number
    3009096682
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    5475 Rings Road, Suite 550
    City
    Dublin
    State
    OH
    ZIP
    43017
    Country
    US

    Regulatory Submissions

    510(k) Number
    K112271

    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
    Generator, Oxygen, Portable CAW
    Oximeter DQA
    Ventilator, Continuous, Non-Life-Supporting MNS

    Proprietary Names

    Rio II Nasal Pillows Interface (P2) - K112271(Device Modification) – 3B Willow((3B WillowTM Nasal Mask)) iCodeConnect Luna II/Auto Luna II CPAP and Auto CPAP System (Luna II QX CPAP and Auto CPAP System) Phoenix Pulse Portable Oxygen Concentrator PHOENIX 5 Oxygen Concentrator Siesta full face mask; Siesta nasal mask (F5A; N5B) iOTM Mini Nasal Mask (Ivolve Nasal Mask, Ivolve Full Face Mask, Ivolve N2) Oximeter DEVILBISS INTELLIPAP MODEL DV 5 SERIES DEVILBISS INTELLIPAP/SLEEPCUBE BILEVEL S/ST React Health Portable Oxygen Concentrator POC2000 RESmart CPAP and Auto CPAP (3B RESMART CPAP AND AUTO CPAP, BMC RESMART CPAP AND AUTO CPAP) DEVILBISS INTELLIPAP/ SLEEPCUBE BILEVEL ST, DV56 ST SERIES G3 B25VT G3 B30VT Luna G3 APAP Luna G3 CPAP Luna G3 BPAP 25A G3X APAP Generator, oxygen, portable Luna G3 BPAP 25/30VT RESmart® BPAP 25A (3B RESMART BPAP 25A, BMC RESMART BPAP 25A) DEVILBISS INTELLIPAP / SLEEPCUBE AUTO BILEVEL 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)) Noncontinuous Ventilator (IPPB) - Auto CPAP System - M1 Mini

    Establishment Types

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