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MALLINCKRODT

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
80208893003382061Mallinckrodt Medical1N2026-01-01CORNAMADDY ATHLONE Westmeath IE --
96806613002808696Mallinckrodt Dar S.r.l.1N2026-01-01VIA G.BOVE, 2/4/6/8 MIRANDOLA Modena IT 41037
30045315883004531588Mallinckrodt Manufacturing LLC1N2026-01-016603 Femrite Dr MADISON WI US 53718
30091403763009140376MALLINCKRODT HOSPITAL PRODUCTS, INC.1N2026-01-01675 McDonnell Blvd Hazelwood MO US 63042
30093526262350054Mallinckrodt Manufacturing LLC1N2026-01-011060 Allendale Dr Port Allen LA US 70767
30145279333014074925MALLINCKRODT HOSPITAL PRODUCTS INC.1N2026-01-01440 Route 22 East Suite 302 Bridgewater NJ US 08807
30134288513013428851MALLINCKRODT PHARMACEUTICALS IRELAND LTD1N2020-04-25College Business & Technology Park Cruiserath Road Blanchardstown Dublin IE D15 TX2V

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
00810055280162INOmax - EVOLVE PUC Kit Upstream IM, BCG+1(877)566-9466CritCare-csmail@mnk.com
00810055280179INOmax - EVOLVE PUC Kit Downstream IM, BCG+1(877)566-9466CritCare-csmail@mnk.com
00810055281244INOmax - Extension, 15mm (6 inches) Pediatric+1(877)566-9466CritCare-csmail@mnk.com
10810055280107INOmax - EVOLVE PRE-USE CHECKOUT KIT, BCG+1(877)566-9466CritCare-csmail@mnk.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2099621042995606P860003UVAR PHOTOPHERESIS SYSTEMLNR1987-04-08
2178271521083273P860003UVAR PHOTOPHERESIS SYSTEMLNR1987-04-08
838951540653818K993268MALLINCKRODT DAR HEATED WIRE BREATHING CIRCUITBTT2000-04-19
832791955440501K993257.010 SILVERSPEED HYDROPOPHILIC GUIDEWIRE, .014 SILVERSPED HYDROPHILIC GUIDEWIRE, .016 SILVERSPEED HYDROPHILIC GUIDEWIDQX1999-10-21
832791106477971K982543SILVERSTREAK HYDROPHILIC GUIDEWIREDQX1998-12-11
832792015791790K965132HI-LO EVAC AND EVAC II ENDOTRACHEAL TUBESBTR1997-03-20
832791614059379K962173SHIKEY TRACHEOSTOMY TUBES AND ACCESSORIESJOH1996-10-04
838951832043296K962045ANESTHESIA BREATHING CIRCUIT/ANESTHESIA BREATHING KITCAH1996-11-26
838951569765793K953400GUEDEL AIRWAYCAE1995-10-24
838951985344843K953295ANESTHESIA FACE MASKBSJ1995-08-11
838951588243808K952036FLEXLIFEBYD1995-06-08
838951340311410K945407SSVO PHONATE(TM) SHILEY SPEAKING VALVE WITH OXYGEN PORTBTO1995-02-27
838951472113617K945406SSV PHONATE(TM) SHILEY SPEAKING VALVEBTO1995-02-27
838951546133538K944124SPIROBAC ADAPTERSCAH1994-09-08
838951340737589K942794HYGROLIFEBYD1994-08-22
838951226756953K942392AIRWAY CONNECTOR WITH FLEX TUBEBZA1994-08-22
838951015654582K941676STERIVENT AND STERIVENT SCAH1994-05-20
838952072756283K941585HYGROSTERBYD1994-04-19
838952031538333K941536BARRIERBAC AND BARRIERBAC SCAH1994-04-19
838952071886021K941535TRACHEOLIFEBYD1994-04-15
838951165825022K941381HYGROBAC,S HYGROBOY AND HYGROBABYCAH1994-04-15
832791477596294K940634MICRO THERAPEUTICS INFUSION CATHETERFOZ1994-10-14
832791341609698K912240CPAP SYSTEM AND BRONCHO-CATH W/CPAP SYSTEMBYE1991-08-22
832791905411603K873461LASER-FLEX(TM) TRACHEAL TUBE (CUFFED)BTR1987-11-06
832791982778552K871204CUFFED TRACHEAL TUBE (MULTIPLE)BTR1987-04-21
832791544325275K862666UNCUFFED LASER RESISTEANT TRACHEAL TUBE(TENTATIVE)BTR1986-08-01
1303852053284094K843640XENON XE 127/XE 133 GAS DISPENSERIYT1985-01-14
1303851742265936K822625SYNTEVENT ATOMIZER/NEBULIZER AEROSOLCCQ1982-10-13
832791934003680K790575TUBE, ARMORED TRACHEALBTR1979-04-13
832792072637899K771219BRONCHO-CATHBTS1977-08-04
832791757219634K251313Shiley™ Adult Flexible Tracheostomy Tube XLT with TaperGuard™ Cuff, Distal with Disposable Inner Cannula; Shiley™ Adult Flexible Tracheostomy Tube XLT with TaperGuard™ Cuff, Proximal with Disposable Inner Cannula; Shiley™ Adult Flexible Tracheostomy Tube XLT Cuffless, Distal with Disposable Inner Cannula ; Shiley™ Adult Flexible Tracheostomy Tube XLT Cuffless, Proximal with Disposable Inner Cannula; Shiley™ Adult Flexible Disposable Inner Cannula XLTJOH2025-12-29
832791864344152K250173Shiley™ Oral RAE Tracheal Tube Cuffless, Murphy Eye (113-XX) Shiley™ Nasal RAE Tracheal Tube Cuffless, Murphy Eye (114-XX) Shiley™ Oral RAE Tracheal Tube Cuffed, Murphy Eye (115-XX) Shiley™ Oral RAE Tracheal Tube with TaperGuard™ Cuff, Murphy Eye (115-XXOR) Shiley™ Nasal RAE Tracheal Tube with TaperGuard™ Cuff, Murphy Eye (119-XXNR)BTR2025-10-06
832791574502810K243785Shiley™ Oral/Nasal Tracheal Tube with TaperGuard™ Cuff Reinforced, Murphy Eye Shiley™ Tracheal Tube TaperGuard™ Cuff Reinforced with Stylet Shiley™ Lo-Contour Oral/Nasal Tracheal Tube Cuffed Reinforced Shiley™ Lo-Contour Oral/Nasal Tracheal Tube Cuffed Reinforced, Murphy Eye Shiley™ Oral/Nasal Tracheal Tube Cuffless ReinforcedBTR2025-09-25
2178272043275700K242578EVOLVE Nitric Oxide Delivery SystemMRN2025-01-03
1894841020074360K222930Evolve Nitric Oxide Delivery SystemMRN2023-12-06
1894841437801918K211153Inomax DSIRMRN2023-04-20
832792013288208K193077Shiley Adult Flexible Evac Tracheostomy Tube with TaperGuard CuffJOH2020-06-01
838951815800998K162738Puritan Bennett 980 Ventilator SystemCBK2017-10-27
832791106658990K150844Shiley Adult Flexible Tracheostomy Tube Cuffless, Reusable Inner Cannula, Shiley Adult Flexible Tracheostomy Tube with TaperGuard Cuff, Reusable Inner CannulaJOH2015-07-14
2178271039170530K143213INOmax DSIR Plus MRIMRN2015-07-10
1894841190489367K143213INOmax DSIR Plus MRIMRN2015-07-10
832791682563834K142296Shiley Adult Flexible Tracheostomy Tube Cuffless, Disposable Inner Cannula; Shiley Adult Flexible Tracheostomy Tube with TaperGuard Cuff, Disposable Inner CannulaJOH2015-02-24
1894841067548136K131686INOMAX DSIR (DELIVERY SYSTEM)MRN2013-11-29
2178272009345501K131686INOMAX DSIR (DELIVERY SYSTEM)MRN2013-11-29
838951121271255K131252PURITAN BENNETT 980 SERIES VENTILATOR SYSTEMCBK2014-02-24
1894841734980997K130605INOMAX DSIR (DELIVERY SYSTEM)MRN2013-05-02
832791305913777K124007SILVERSPEED HYDROPHILIC GUIDEWIRE, X-CELERATOR HYDROPHILIC EXCHANGE GUIDEWIRE, X-PEDION HYDROPHILIC GUIDEWIRE, MIRAGE HYDQX2013-03-07
1894841145774708K122689INOBLENDERMRO2012-11-07
1894841201112547K121021INOMAX DS (DELIVERY SYSTEM)MRN2012-09-24
1894841230387697K113272INOMAX DS(DELIVERY SYSTEMSMRN2012-02-29
1894841459522461K110635INOMAX DS(IR) (DELIVERY SYSTEM)MRN2011-06-23
1894841068694896K110344INOMAX DSIR (DELIVERY SYSTEM)MRN2011-06-24
1894841658927279K093922INOMAX DSMRN2010-04-15
1894841877404729K092545INOMAX DS (DELIVERY SYSTEM), MODEL 10003MRN2010-03-10
1894841377532268K090958INOMAX DS (DELIVERY SYSTEM)MNR2009-06-18
838951574797432K082966PB 540 VENTILATORCBK2008-10-31
832791774043043K082520SEALGUARD EVAC ENDOTRACHEAL AND ENDOTRACHEAL TUBESBTR2008-10-02
1894841639442935K081691INOMAX DS (DELIVERY SYSTEM)MRN2008-08-28
1894841937418504K080484INOMAX DS (DELIVERY SYSTEM), MODEL 10003MRN2008-08-06
1894841302471146K071516INOMAX DSMRN2007-10-03
1894841649853508K070867INOMAX DS (DELIVERY SYSTEM), MODEL 10003MRN2007-04-27
1894841331954026K061901INO THERAPEUTICS INOMAX DS (DELIVERY SYSTEM), MODEL 10003MRN2006-12-14
1894841094514987K052663INO THERAPEUTICS INOBLENDER, MODEL 10004MRO2005-11-04
832792034347573K051416SHILEY TRACHEOSOFT XLT EXTENDED LENGTH TRACHEOSTOMY TUBE AND INNER CANNULAJOH2005-06-16
838951531923441K031997MALLINCKRODT DAR TY-CARE / TY-CARE EXEL CLOSED SUCTION SYSTEMBSY2003-11-25
832791326507754K010497SILVERSPEED HYDROPHILIC GUIDEWIRE, MODELS 103-0601-300 AND 103-0602-300DQX2001-03-22
832791173718251K002212MIRAGE HYDROPHILIC GUIDEWIRE, MODEL 103-0608DQX2000-08-03
832791415926156K001454SILVERSPEED HYDROPHILIC GUIDEWIRE (0.014 DIAMETER, 145CM LENGTH, SUPPORT) SILVERSPEED HYDROPHILIC GUIDEWIRE (0.014 DDQX2000-06-07
1894841304021725K000186DATEX-OHMEDA INOVENT DELIVERY SYSTEMMRN2000-02-10
838951004778700
838951240516603
838951463292085
838951663408158
832791126940552
1894851156191822
838951231719377
1894841268102061
838951293672021
1894841463481764
1303851499273612
1303851521277656
1303851593938434
1894841726842571
838951767029122
1303851803982152
2178272039935296

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
MRN202025-01-03
BTR92025-10-06
JOH62025-12-29
DQX62013-03-07
CAH61996-11-26
BYD41995-06-08
CBK32017-10-27
MRO22012-11-07
BTT22000-04-19
BTO21995-02-27
LNR21987-04-08
MNR12009-06-18
BSY12003-11-25
CAE11995-10-24
BSJ11995-08-11
FOZ11994-10-14
BZA11994-08-22
BYE11991-08-22
IYT11985-01-14
CCQ11982-10-13
BTS11977-08-04

NDC#

PMA#

102 records. Showing 1-40. Next

PMN#

180 records. Showing 1-40. Next

Applications#

50 records. Showing 1-40. Next

GUDID#

80 records. Showing 1-40. Next