3B MEDICAL INC

FDA Device Registration & Listing · W Jefferson, OH, US · Registration 3042507287

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
3042507287
FEI Number
3042507287
Entity Name
3B MEDICAL INC
City/State/Country
W Jefferson, OH, US
Establishment Address
1054 Gateway Park Dr, W Jefferson, OH 43162, US
Establishment Type(s)
Repack or Relabel Medical Device
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
K112271
PMA Number
N/A

All Registered 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 Optiflow 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))

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
BTT Humidifier, Respiratory Gas, (Direct Patient Interface) Anesthesiology Class 2 868.5450 2026-02-25
CAW Generator, Oxygen, Portable Anesthesiology Class 2 868.5440 2026-02-25
CAW Generator, Oxygen, Portable Anesthesiology Class 2 868.5440 2026-02-25
BZD Ventilator, Non-Continuous (Respirator) Anesthesiology Class 2 868.5905 2023-01-17
CAW Generator, Oxygen, Portable Anesthesiology Class 2 868.5440 2020-04-22
CAW Generator, Oxygen, Portable Anesthesiology Class 2 868.5440 2026-02-25
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
BZD Ventilator, Non-Continuous (Respirator) Anesthesiology Class 2 868.5905 2023-01-17
CAT Cannula, Nasal, Oxygen Anesthesiology Class 1 868.5340 2026-02-25
CAW Generator, Oxygen, Portable Anesthesiology Class 2 868.5440 2026-02-25
BZD Ventilator, Non-Continuous (Respirator) Anesthesiology Class 2 868.5905 2022-03-29
CAW Generator, Oxygen, Portable Anesthesiology Class 2 868.5440 2026-02-25
BZD Ventilator, Non-Continuous (Respirator) Anesthesiology Class 2 868.5905 2023-01-17

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
3009096682 3B Medical Inc Dublin, 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
K012633 Respironics, Inc. RESPIRONICS HEATED HUMIDIFIER 2002-02-28
K970478 Marquest Medical Products, Inc. SCT 3000 HEATED HUMIDIFIER 1997-07-16

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.

Similar Registrations

Registration Number Establishment Name Location
3012667060 HMC Premedical S.p.A. Medolla Modena, IT
3013505405 BMC (Tianjin) Medical Co., Ltd. Wuqing District Tianjin, CN
3033530343 BMC INVESTMENT HOLDING LIMITED Hong Kong, HK
3017684630 ResMed Asia Pte. Ltd. Singapore South West, SG
3004802249 W&S PLASTICS PTY LTD Moorebank New South Wales, AU
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3042507287. Last updated year: 2026. Please use registration number 3042507287 when referencing this establishment in official correspondence.
Legal Disclaimer: AvaSpecs is not affiliated with the FDA or any government agency and does not provide medical, legal, regulatory, safety, approval, clearance, effectiveness, endorsement, or compliance advice. This index page is built using public record archives and does not represent an official regulatory determination.
Account Required Full available specs will require a free AvaSpecs account.