3B Medical Inc

FDA Device Registration & Listing · Dublin, OH, US · Registration 3009096682

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3009096682
FEI Number
3009096682
Entity Name
3B Medical Inc
City/State/Country
Dublin, OH, US
Establishment Address
5475 Rings Road, Suite 550, Dublin, OH 43017, US
Establishment Type(s)
Complaint File Establishment per 21 CFR 820.198
Owner / Operator
React Health (Owner Number: 10040143)
Owner / Operator Contact Address
5475 Rings Road, Suite 550, Dublin, OH 43017, US
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
K212263
PMA Number
N/A

All Registered 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

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
BZD Ventilator, Non-Continuous (Respirator) Anesthesiology Class 2 868.5905 2023-01-17
BZD Ventilator, Non-Continuous (Respirator) Anesthesiology Class 2 868.5905 2023-01-17
BZD Ventilator, Non-Continuous (Respirator) Anesthesiology Class 2 868.5905 2021-04-05
CAW Generator, Oxygen, Portable Anesthesiology Class 2 868.5440 2026-02-05
CAW Generator, Oxygen, Portable Anesthesiology Class 2 868.5440 2025-05-02
BZD Ventilator, Non-Continuous (Respirator) Anesthesiology Class 2 868.5905 2023-01-17
DQA Oximeter Cardiovascular Class 2 870.2700 2021-05-04
BZD Ventilator, Non-Continuous (Respirator) Anesthesiology Class 2 868.5905 2024-02-19
BZD Ventilator, Non-Continuous (Respirator) Anesthesiology Class 2 868.5905 2024-02-19
CAW Generator, Oxygen, Portable Anesthesiology Class 2 868.5440 2024-01-22
BZD Ventilator, Non-Continuous (Respirator) Anesthesiology Class 2 868.5905 2023-01-17
MNS Ventilator, Continuous, Non-Life-Supporting Anesthesiology Class 2 868.5895 2024-02-19
MNS Ventilator, Continuous, Non-Life-Supporting Anesthesiology Class 2 868.5895 2026-06-10
BZD Ventilator, Non-Continuous (Respirator) Anesthesiology Class 2 868.5905 2026-06-10
CAW Generator, Oxygen, Portable Anesthesiology Class 2 868.5440 2020-04-22
BZD Ventilator, Non-Continuous (Respirator) Anesthesiology Class 2 868.5905 2022-03-29

Official Correspondent

Shalini Yadav

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

React Health
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3042507287 3B MEDICAL INC W Jefferson, OH, US

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K792722 Novametrix Medical Systems, Inc. NOVAMETRIX CPAP NASAL CANNULA 1980-01-24
K082979 Resmed, Ltd. S8 ADVANCE 2009-01-02
K203126 Resmed Pty , Ltd. S10 Kirra 2020-12-18
K003939 Invacare Corp. VENTURE HOME FILL II, MODEL IOH 200 2001-03-21
K942357 Healthdyne, Inc. H-500 ALLIANCE OXYGEN CONCENTRATOR 1994-05-27

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0009-2020 TELEFLEX-MORRISVILLE 2
Babi.Plus 12.5 cm H2O Pressure Relief Manifold Catalog # 2691 for use with ventilators.
Z-0020-2020 Galemed Corporation 87 Wu-Jia Li-Gong 2nd Road I-Lan Taiwan 2
Babi.Plus 12.5 cm H2O Pressure Relief Manifold, REF 1030, RX Only, UDI: 04710810093562
Z-0021-2020 Galemed Corporation 87 Wu-Jia Li-Gong 2nd Road I-Lan Taiwan 2
Babi.Plus Bubble PAP Valve with 12.5 cm H2O Pressure Relief Manifold, REF 1002, Rx Only, UDI: 24710810093559
Z-0022-2020 Galemed Corporation 87 Wu-Jia Li-Gong 2nd Road I-Lan Taiwan 2
Babi.Plus 12.5 cm H2O Pressure Relief Manifold with Gas Supply Tube and Oxygen Sensor Port, REF 2691, Rx Only, UDI: 04710810100802
Z-0038-2007 Sunrise Medical 2
DeVilbiss iFill Personal Oxygen Station model number 535D.

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3042507287 3B MEDICAL INC W Jefferson, OH, US
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009096682. Last updated year: 2026. Please use registration number 3009096682 when referencing this establishment in official correspondence.
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