FDA.reportPublic FDA data

Datex-Ohmeda

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
21126672112667Datex-Ohmeda, Inc.1Y2026-01-013030 Ohmeda Drive MADISON WI US 53718
30142207483014220748Datex-Ohmeda, Inc.1N2026-01-019900 Innovation Drive Wauwatosa WI US 53226
30364706793036470679Datex-Ohmeda, Inc.1N2026-01-013114 N Grandview Blvd Waukesha WI US 53188

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
00840682103923Giraffe - GIRAFFE WARMER+1(800)345-2700xx@xx.xx
00840682152709Panda - Panda iRes Warmer V1.0+1(999)999-9999xx@xx.xx

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
266212047727730P210018Et ControlQSF2022-03-17
266211138888134K993410DATES-OHMEDA AESTIVA SMARTVENT MRIBSZ2000-04-25
2392501665070206K993407OHMEDA MEDICAL OMNIBEDFMZ2000-01-05
266211520648859K990132DATEX-OHMEDA ANESTHESIA VAPORIZER, MODEL D-TECCAD1999-01-21
2392501334370594K974349OHMEDA-OHIO CARE PLUS INCUBATORFMZ1998-02-12
2392501355129694K971243OHMEDA INFANT RESUSCITATION SYSTEMBTM1997-12-02
2392501545775620K963058INFANT WARMER SYSTEMFMT1996-10-01
2392501357814808K962806OHMEDA-OHIO CAE PLUS INCUBATORFMZ1996-09-20
2392501052191830K943360OHIO CARE PLUS INCUBATORFMZ1994-09-29
266211526358597K925580OHMEDA TEC 6 (CFV) CONTINUOUS FLOW VAPORIZER, NADBSZ1993-06-02
2392502028912771K921766OHIO INFANT WARMER SYSTEMFMT1993-04-23
2392501542030580K914487OHIO CARE PLUS INCUBATORFMZ1991-12-18
266211845199616K913593OHMEDA TEC 6 CONTINUOUS FLOW VAPORIZERCAD1992-10-06
2392501417181997K913154OHMEDA - OHIO CAR PLUS INCUBATOR, MODIFICATIONFMZ1991-09-13
2392501710006005K901585OHMEDA - OHIO(R) CARE PLUS INCUBATORFMZ1990-06-22
2392501451090475K894129BILIBLANKET PHOTOTHERAPY DEVICELBI1989-09-28
2392501824346668K884160OHMEDA - OHIO(R) 3500 INFANT WARMER SYSTEMFMT1988-11-21
2392501328078512K871399OHIO(R) CARE PLUS INCUBATORFMZ1987-06-05
266211799470236K863207OHMEDA 'B' SERIES GAS DELIVERY SYSTEMBSZ1986-10-30
2392501975797394K851449OHMEDA 5000 INFANT WARMER SYSTEMFMT1985-06-07
2392501967523526K251663Giraffe OmniBed Carestation (CS1); Giraffe Incubator Carestation (CS1)FMZ2025-10-22
3377801967523526K251663Giraffe OmniBed Carestation (CS1); Giraffe Incubator Carestation (CS1)FMZ2025-10-22
2392501268411222K231964Novii+ Wireless Patch SystemHGM2023-12-08
3377801268411222K231964Novii+ Wireless Patch SystemHGM2023-12-08
266211795760255K213867Carestation 750/750cBSZ2023-03-28
2392501160605239K213553Giraffe Incubator Carestation CS1FMZ2022-03-02
3377801160605239K213553Giraffe Incubator Carestation CS1FMZ2022-03-02
2392501410950676K213551Giraffe Omnibed Carestation CS1FMT2022-03-02
3377801410950676K213551Giraffe Omnibed Carestation CS1FMT2022-03-02
266212060421334K210384CARESCAPE R860CBK2021-11-04
2392501354832526K201628Panda iRes Warmer, Giraffe WarmerFMT2021-02-12
3377801354832526K201628Panda iRes Warmer, Giraffe WarmerFMT2021-02-12
266211262565014K172702Tec 820, Tec 850CAD2018-01-04
266211811624773K172045Aestiva 7900, Aestiva MRI, Aestiva 7100, Aestiva 7100 Compact, Aespire 100, Aespire 7100, Aespire 7900, Aespire View, Avance, Avance CS2, Aisys, Aisys CS2BSZ2017-11-03
266211006184887K170872Aisys CS2BSZ2017-08-15
266211552672737K152814Giraffe OmniBed Carestation CS1FMZ2016-03-17
2392501552672737K152814Giraffe OmniBed Carestation CS1FMZ2016-03-17
3377801552672737K152814Giraffe OmniBed Carestation CS1FMZ2016-03-17
266211441303701K152809Giraffe Incubator Carestation CS1FMZ2015-12-31
2392501441303701K152809Giraffe Incubator Carestation CS1FMZ2015-12-31
3377801441303701K152809Giraffe Incubator Carestation CS1FMZ2015-12-31
266211918514421K151570Carestation 620/650/650CBSZ2016-01-21
266211534348241K143530Aespire ViewBSZ2015-04-24
266211621841643K142679CARESCAPE R860CBK2015-06-12
2392501171009157K140862MONICA NOVII WIRELESS PATCH SYSTEMOSP2014-08-27
3377801171009157K140862MONICA NOVII WIRELESS PATCH SYSTEMOSP2014-08-27
266211619774425K140575ENGSTROM CARESTATION, ENGSTROM PROCBK2015-02-03
266211391063557K132530GE DATEX-OHMEDA AISYS CS2 (AISYS CS^2)BSZ2013-12-20
266211269347215K131945GE DATEX-OHMEDA AVANCE CS2BSZ2013-08-08
266211859804526K123309GIRAFFE AND PANDA WARMERSFMT2013-02-05
2392501859804526K123309GIRAFFE AND PANDA WARMERSFMT2013-02-05
3377801859804526K123309GIRAFFE AND PANDA WARMERSFMT2013-02-05
266211058088170K123125GE DATEX-OHMEDA AVANCE CS2BSZ2013-02-06
266211838173866K122445AESPIRE 7900, AESPIRE VIEWBSZ2012-10-12
266211092803652K122267GIRAFFE AND PANDA WARMERSFMT2012-10-02
2392501092803652K122267GIRAFFE AND PANDA WARMERSFMT2012-10-02
3377801092803652K122267GIRAFFE AND PANDA WARMERSFMT2012-10-02
2392501295245947K121625LULLABY TM WARMERFMT2012-09-14
3377801295245947K121625LULLABY TM WARMERFMT2012-09-14
2392501286107523K120820GIRAFFE BLUE SPOT PT LITELBI2012-06-08
3377801286107523K120820GIRAFFE BLUE SPOT PT LITELBI2012-06-08
2392502067999729K120168LULLABY LED PHOTTHERAPY SYSTEMLBI2012-05-02
3377802067999729K120168LULLABY LED PHOTTHERAPY SYSTEMLBI2012-05-02
266211987710570K112754IVENT101CBK2012-06-15
266212012150161K112722GE DATEX-OHMEDA AVANCEBSZ2011-12-16
266211038426262K111116ENGSTROM CARESTATION, ENGSTROM PRO, MODELS 1505-9000-000, 1505-9003-000CBK2011-09-09
266211503357938K110213GE DATEX-OHMEDA AISYSBSZ2011-07-20
266212050581818K101804GIRAFFE AND PANDA WARMERSFMT2010-07-21
2392502050581818K101804GIRAFFE AND PANDA WARMERSFMT2010-07-21
3377802050581818K101804GIRAFFE AND PANDA WARMERSFMT2010-07-21
266211501442077K101788GIRAFFE OMNIBEDFMZ2010-07-21
2392501501442077K101788GIRAFFE OMNIBEDFMZ2010-07-21
3377801501442077K101788GIRAFFE OMNIBEDFMZ2010-07-21
266211528510167K101778GIRAFFE INCUBATORFMZ2010-07-21
2392501528510167K101778GIRAFFE INCUBATORFMZ2010-07-21
3377801528510167K101778GIRAFFE INCUBATORFMZ2010-07-21
266211325523304K093886ENGSTROM CARESTATION, ENGSTROM PROCBK2010-05-03
266211947375370K092864AESPIRE 7900, AESPIRE VIEWBSZ2010-01-12
266211551927002K092135MODIFICATION TO IVENT 101CBK2009-11-23
266211183577111K090697MODIFICATION TO: GIRAFFE AND PANDA WARMERFMT2009-04-16
2392501183577111K090697MODIFICATION TO: GIRAFFE AND PANDA WARMERFMT2009-04-16
3377801183577111K090697MODIFICATION TO: GIRAFFE AND PANDA WARMERFMT2009-04-16
266211895262041K090233GE DATEX-OHMEDA AISYSBSZ2009-03-05
266211535801874K081844GE DATEX-OHMEDA AVANCEBSZ2008-08-29
266211539154270K081842ENGSTROM CARESTATION, ENGSTROM PROCBK2008-10-03
266211981367376K073707GE DATEX-OHMEDA AISYSBSZ2008-01-30
266211702378223K073694IVENT 2001 MRI CONDITIONALCBK2008-05-30
2392501966626483K072512MODIFICATION TO: OHMEDA MEDICAL GIRAFFE INCUBATOR (GIRAFFE AND PANDA UNINTERRUPTIBLE POWER SUPPLY)FMZ2007-10-03
2392501274175530K072157MODIFICATION TO GIRAFFE AND PANDA WARMERS (GIRAFFE AND PANDA UNINTERRUPTIBLE POWER SUPPLY)FMT2007-08-27
3377801274175530K072157MODIFICATION TO GIRAFFE AND PANDA WARMERS (GIRAFFE AND PANDA UNINTERRUPTIBLE POWER SUPPLY)FMT2007-08-27
2392501612161729K071828LULLABYLBI2007-08-06
266211785679085K071142GE DATEX-OHMEDA AVANCE ANESTHESIA SYSTEMBSZ2007-06-06
266211081523357K070377GIRAFFE AND PANDA WARMERFMT2007-07-11
2392501081523357K070377GIRAFFE AND PANDA WARMERFMT2007-07-11
3377801081523357K070377GIRAFFE AND PANDA WARMERFMT2007-07-11
266211395478094K070247GIRAFFE AND PANDA BAG AND MASK RESUSCITATION SYSTEMBTM2007-04-20
2392501395478094K070247GIRAFFE AND PANDA BAG AND MASK RESUSCITATION SYSTEMBTM2007-04-20
3377801395478094K070247GIRAFFE AND PANDA BAG AND MASK RESUSCITATION SYSTEMBTM2007-04-20
266211800776822K070210GIRAFFE AND PANDA T- PIECE RESUSCITATION SYSTEMBTL2007-04-20
2392501800776822K070210GIRAFFE AND PANDA T- PIECE RESUSCITATION SYSTEMBTL2007-04-20
3377801800776822K070210GIRAFFE AND PANDA T- PIECE RESUSCITATION SYSTEMBTL2007-04-20
266211175040691K062710GE DATEX-OHMEDA ENGSTROM CARESTATIONCBK2006-12-08
266211876687519K061609GE DATEX-OHMEDA AISYSBSZ2006-06-27
266211721199903K060862GE DATEX-OHMEDA ENGSTROM CARESTATIONCBK2006-06-05
2392501969581093K053568BILISOFT PHOTOTHERAPY SYSTEMLBI2006-04-17
3377801969581093K053568BILISOFT PHOTOTHERAPY SYSTEMLBI2006-04-17
266211890824980K051895GE DATEX-OHMEDA ENGSTROM CARESTATIONCBK2005-09-27
266211352805657K050860GE DATEX-OHMEDA CENTIVA/5 VENTILATORCBK2005-06-21
266211041266266K050626GE DATEX-OHMEDA AESPIRE 7900 ANESTHESIA SYSTEMBSZ2005-03-25
266211241291398K050055GE DATEX-OHMEDA AESTIVA/5 MRI ANESTHESIA SYSTEMBSZ2005-02-04
266211878139550K040743MODIFICATION TO DATEX-OHMEDA S/5 AVANCE ANESTHESIA SYSTEMBSZ2004-04-22
2392501506699234K040068BILIBLANKET PLUS HIGH OUTPUT PHOTOTHERAPY SYSTEMFMZ2004-04-16
266211296176081K031027DATEX-OHMEDA TEC 7 ANESTHESIA VAPORIZER (ENFLURANE)CAD2003-06-26
266211468055568K023366DATEX-OHMEDA 7900 VENTILATOR ENHANCEMENTSCBK2003-10-07
266211316358309K020547OHMEDA MEDICAL GIRAFFE INCUBATORFMZ2002-05-09
2392501316358309K020547OHMEDA MEDICAL GIRAFFE INCUBATORFMZ2002-05-09
2392501415592203K020543OHMEDA MEDICAL GIRAFFE OMNIBEDFMZ2002-05-09
3377801415592203K020543OHMEDA MEDICAL GIRAFFE OMNIBEDFMZ2002-05-09

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
FMZ322025-10-22
FMT272022-03-02
BSZ262023-03-28
CBK152021-11-04
LBI92012-06-08
CAD72018-01-04
BTM42007-04-20
BTL32007-04-20
HGM22023-12-08
OSP22014-08-27
QSF 12022-03-17

PMA#

Et Control

2022-03-17

Datex-Ohmeda, Inc., A General Electric Companyp.o. Box 7550madison, WI 53707-7550 PMA NumberP210018 Date Received05/03/2021 Decision Date03/17/2022 Product Code QSF  Advisory Committee Anesthesiology Clinical TrialsNCT02972892 Expedited Review Granted? No

PMN#

102 records. Showing 1-40. Next

GUDID#

80 records. Showing 1-40. Next