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Mallinckrodt Manufacturing LLC

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30045315883004531588Mallinckrodt Manufacturing LLC1N2026-01-016603 Femrite Dr MADISON WI US 53718
30093526262350054Mallinckrodt Manufacturing LLC1N2026-01-011060 Allendale Dr Port Allen LA US 70767

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
00810055280063INOmax - Evolve System Assembly US+1(877)566-9466CritCare-csmail@mnk.com
00810055280070INOmax - Evolve Cart US+1(877)566-9466CritCare-csmail@mnk.com
00810055280100INOmax - EVOLVE PRE-USE CHECKOUT KIT, BCG+1(877)566-9466CritCare-csmail@mnk.com
00810055280117INOmax - Evolve Bunnell Life Pulse Conv Pack with Natvar+1(877)566-9466CritCare-csmail@mnk.com
00810055280131INOmax - Evolve Sensormedics 3100A/B UnFiltered Conv Pac+1(877)566-9466CritCare-csmail@mnk.com
00810055280148INOmax - Evolve Injector Tube+1(877)566-9466CritCare-csmail@mnk.com
00810055280155INOmax - Evolve Gas Filter and Sample Line+1(877)566-9466CritCare-csmail@mnk.com
00810055281244INOmax - Extension, 15mm (6 inches) Pediatric+1(877)566-9466CritCare-csmail@mnk.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1894841020074360K222930Evolve Nitric Oxide Delivery SystemMRN2023-12-06
1894841437801918K211153Inomax DSIRMRN2023-04-20
1894841190489367K143213INOmax DSIR Plus MRIMRN2015-07-10
1894841067548136K131686INOMAX DSIR (DELIVERY SYSTEM)MRN2013-11-29
1894841734980997K130605INOMAX DSIR (DELIVERY SYSTEM)MRN2013-05-02
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
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
1894841304021725K000186DATEX-OHMEDA INOVENT DELIVERY SYSTEMMRN2000-02-10
1894851156191822
1894841268102061
1894841463481764
1894841726842571

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
MRN172023-12-06
MRO22012-11-07
MNR12009-06-18

PMN#

GUDID#

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