FDA.reportPublic FDA data

3B Medical Inc

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
300909668230090966823B Medical Inc1Y2026-01-015475 Rings Road Suite 550 Dublin OH US 43017
304250728730425072873B MEDICAL INC1Y2026-01-011054 Gateway Park Dr W Jefferson OH US 43162

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
3485861214913061K914488MODELS: IRCRF5, IRCPF16 FLOWMETER ACCESSORY KITSCAW1992-09-15
3485861754847371K243833Portable oxygen concentrator (JAY-1000P)CAW2025-09-29
1394481754847371K243833Portable oxygen concentrator (JAY-1000P)CAW2025-09-29
1394482046969818K223379Portable Oxygen Concentrator (Model: P2-E7, P2-E)CAW2023-06-22
3485861329848547K213210Oxygen Concentrator, Model JAY-5AWCAW2022-12-08
1394481329848547K213210Oxygen Concentrator, Model JAY-5AWCAW2022-12-08
3485861833913952K213169BPAP SystemMNS2022-12-05
1394481833913952K213169BPAP SystemMNS2022-12-05
3485861028448001K212263Luna G3 BPAP SystemBZD2022-03-25
1394481028448001K212263Luna G3 BPAP SystemBZD2022-03-25
1394481326881207K211155Auto CPAP SystemBZD2022-03-09
3485861326881207K211155Auto CPAP SystemBZD2022-03-09
1394481276683144K201620Luna® G3 BPAP 25ABZD2021-01-29
3485861276683144K201620Luna® G3 BPAP 25ABZD2021-01-29
3485861940995530K200890Invacare Perfecto2V Oxygen ConcentratorCAW2020-08-06
3485861004762834K191159Concentrator with Single battery pack, carry bag with shoulder strap, back pack shoulder straps, A, POC1 USB Bluetooth Dongle, POC1 Invacare Mobile Medical Application Accessory for use on iOS and Android Devices, Invacare Platinum Mobile Oxygen Concentrator with ConnectivityCAW2019-08-29
1394482016581850K172234Oxygen ConcentratorCAW2018-06-01
3485862016581850K172234Oxygen ConcentratorCAW2018-06-01
1394481247644754K163464Viva Nasal Mask (Model: NM4), Numa Full Face Mask (Model: BMC-FM2)BZD2017-09-05
3485861247644754K163464Viva Nasal Mask (Model: NM4), Numa Full Face Mask (Model: BMC-FM2)BZD2017-09-05
3485862051170874K162877VOCSN Unified Respiratory SystemCBK2017-04-07
3485861715592229K160630Invacare Platinum Mobile Oxygen ConcentratorCAW2016-09-27
1394481593267626K160127iCodeConnectBZD2016-11-10
3485861682555815K153387Luna CPAP and Auto CPAP SystemBZD2016-09-08
1394481682555815K153387Luna CPAP and Auto CPAP SystemBZD2016-09-08
1394481438169532K143677DeVilbiss Intellipap2/DeVilbiss BLUEBZD2015-09-18
1394481249724555K1337693B RESMART BPAP 25A, BMC RESMART BPAP 25ABZD2014-08-25
1394481503060093K1329673B RESMART CPAP AND AUTO CPAP, BMC RESMART CPAP AND AUTO CPAPBZD2013-12-06
3485861735588750K131901IVOLVE NASAL MASK, IVOLVE FULL FACE MASK, IVOLVE N2BZD2013-12-23
1394481735588750K131901IVOLVE NASAL MASK, IVOLVE FULL FACE MASK, IVOLVE N2BZD2013-12-23
1394481739285527K121260TROOPER OXYGEN CONCENTRATORCAW2012-09-21
1394481962421839K1122713B WILLOWBZD2012-02-16
3485861962421839K1122713B WILLOWBZD2012-02-16
1394481377205357K112220DEVILBISS INTELLIPAP / SLEEPCUBE AUTO BILEVELBZD2011-11-22
1394481374581586K093070DEVILBISS INTELLIPAP/ SLEEPCUBE BILEVEL ST, DV56 ST SERIESMNS2010-01-26
1394481330598269K091919DEVILBISS INTELLIPAP/SLEEPCUBE BILEVEL S/STBZD2009-09-28
1394481146021554K082641FINGERTIP PULSE OXIMETER, MODELS CMS-50D, CMS-50L, CMS-50DLDQA2008-11-10
1394481285333668K071689DEVILBISS INTELLIPAP MODEL DV 5 SERIESBZD2007-09-07
3485861629965521K021685VENTURE HOMEFILL II WITH OXYGEN CONSERVERCAW2002-07-23
3485861420023939K020386INVACARE PLATINUM, MODELS IRC 5LX AND IRC 5LX02CAW2002-07-02
3485861240953514K020332RESPIRATORY HUMIDIFIER, MODEL MR850BTT2003-07-07
1394481598002311
3485861160208977

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
BZD212022-03-25
CAW142025-09-29
MNS32022-12-05
CBK12017-04-07
DQA12008-11-10
BTT12003-07-07

PMN#

Aer X

2020-07-24

3B Medical Inc.

GUDID#

Lumin - Lumin serves as both a general-purpose sanitizing device for personal care items (e.g. cell phone, eyeglasses, keys, etc.) as well as CPAP accessories (e.g. hose, mask, and water chamber. In terms of CPAP sanitizer, there is no requirement for sterility or disinfection for single-patient re-use of CPAP accessories in the home. Most manufacturer instructions require simple cleaning with soap and water. Lumin is intended to be used as an adjunct to following the manufacturer’s instructions for routine cleaning but provides the convenience of bioburden reduction in 5 minutes. Lumin is designed to be used only with the CPAP accessories (i.e. CPAP Mask, hose, and water chamber), and not on the CPAP machine itself.

3b Medical, Inc.

2021-02-01