MALLINCKRODT

FDA Registration(s)#

Registration, FEI, Name table
Registration	FEI	Name	Status	Initial importer	Expiration year	Address
3004531588	3004531588	Mallinckrodt Manufacturing LLC	1	N	2026-01-01	6603 Femrite Dr MADISON WI US 53718
3009140376	3009140376	MALLINCKRODT HOSPITAL PRODUCTS, INC.	1	N	2026-01-01	675 McDonnell Blvd Hazelwood MO US 63042
3009352626	2350054	Mallinckrodt Manufacturing LLC	1	N	2026-01-01	1060 Allendale Dr Port Allen LA US 70767
3014527933	3014074925	MALLINCKRODT HOSPITAL PRODUCTS INC.	1	N	2026-01-01	440 Route 22 East Suite 302 Bridgewater NJ US 08807
3013428851	3013428851	MALLINCKRODT PHARMACEUTICALS IRELAND LTD	1	N	2020-04-25	College 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 GUDID	Product	Phone	Email
00810055280162	INOmax - EVOLVE PUC Kit Upstream IM, BCG	+1(877)566-9466	CritCare-csmail@mnk.com
00810055280179	INOmax - EVOLVE PUC Kit Downstream IM, BCG	+1(877)566-9466	CritCare-csmail@mnk.com
00810055281244	INOmax - Extension, 15mm (6 inches) Pediatric	+1(877)566-9466	CritCare-csmail@mnk.com
10810055280107	INOmax - EVOLVE PRE-USE CHECKOUT KIT, BCG	+1(877)566-9466	CritCare-csmail@mnk.com

mnk.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration key	Listing key	Premarket submission	Device	Product code	Decision date
209962	1042995606	P860003	UVAR PHOTOPHERESIS SYSTEM	LNR	1987-04-08
217827	1521083273	P860003	UVAR PHOTOPHERESIS SYSTEM	LNR	1987-04-08
130385	2053284094	K843640	XENON XE 127/XE 133 GAS DISPENSER	IYT	1985-01-14
130385	1742265936	K822625	SYNTEVENT ATOMIZER/NEBULIZER AEROSOL	CCQ	1982-10-13
217827	2043275700	K242578	EVOLVE Nitric Oxide Delivery System	MRN	2025-01-03
189484	1020074360	K222930	Evolve Nitric Oxide Delivery System	MRN	2023-12-06
189484	1437801918	K211153	Inomax DSIR	MRN	2023-04-20
217827	1039170530	K143213	INOmax DSIR Plus MRI	MRN	2015-07-10
189484	1190489367	K143213	INOmax DSIR Plus MRI	MRN	2015-07-10
189484	1067548136	K131686	INOMAX DSIR (DELIVERY SYSTEM)	MRN	2013-11-29
217827	2009345501	K131686	INOMAX DSIR (DELIVERY SYSTEM)	MRN	2013-11-29
189484	1734980997	K130605	INOMAX DSIR (DELIVERY SYSTEM)	MRN	2013-05-02
189484	1145774708	K122689	INOBLENDER	MRO	2012-11-07
189484	1201112547	K121021	INOMAX DS (DELIVERY SYSTEM)	MRN	2012-09-24
189484	1230387697	K113272	INOMAX DS(DELIVERY SYSTEMS	MRN	2012-02-29
189484	1459522461	K110635	INOMAX DS(IR) (DELIVERY SYSTEM)	MRN	2011-06-23
189484	1068694896	K110344	INOMAX DSIR (DELIVERY SYSTEM)	MRN	2011-06-24
189484	1658927279	K093922	INOMAX DS	MRN	2010-04-15
189484	1877404729	K092545	INOMAX DS (DELIVERY SYSTEM), MODEL 10003	MRN	2010-03-10
189484	1377532268	K090958	INOMAX DS (DELIVERY SYSTEM)	MNR	2009-06-18
189484	1639442935	K081691	INOMAX DS (DELIVERY SYSTEM)	MRN	2008-08-28
189484	1937418504	K080484	INOMAX DS (DELIVERY SYSTEM), MODEL 10003	MRN	2008-08-06
189484	1302471146	K071516	INOMAX DS	MRN	2007-10-03
189484	1649853508	K070867	INOMAX DS (DELIVERY SYSTEM), MODEL 10003	MRN	2007-04-27
189484	1331954026	K061901	INO THERAPEUTICS INOMAX DS (DELIVERY SYSTEM), MODEL 10003	MRN	2006-12-14
189484	1094514987	K052663	INO THERAPEUTICS INOBLENDER, MODEL 10004	MRO	2005-11-04
189484	1304021725	K000186	DATEX-OHMEDA INOVENT DELIVERY SYSTEM	MRN	2000-02-10
189485	1156191822
189484	1268102061
189484	1463481764
130385	1499273612
130385	1521277656
130385	1593938434
189484	1726842571
130385	1803982152
217827	2039935296

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product code	Registration listing records	Latest decision
MRN	20	2025-01-03
MRO	2	2012-11-07
LNR	2	1987-04-08
MNR	1	2009-06-18
IYT	1	1985-01-14
CCQ	1	1982-10-13

NDC#

Terlivaz

Mallinckrodt Hospital Products Inc.

Terlipressin

Acthar

Mallinckrodt ARD LLC

Repository Corticotropin

Acthar

Mallinckrodt ARD LLC

repository corticotropin

Acthar

Mallinckrodt ARD LLC

repository corticotropin

PMA#

THERAKOS CELLEX Photopheresis System (CELLEX), THERAKOS CELLEX Photopheresis Procedural Kit (CLXUSA and CLXECP), THERAKO

2022-09-23

Mallinckrodt Pharmaceuticals Ireland Limitedcollege Business & Technology Parkcruiserath Roadblanchardstown D15 T PMA NumberP860003 Supplement NumberS108 Date Received08/26/2022 Decision Date09/23/2022 Product Code LNR Advisory Committee Gastroenterology/U...

THERAKOS CELLEX Photopheresis System (CELLEX), THERAKOS CELLEX Photopheresis Procedural Kit (CLXUSA and CLXECP),THERAKOS

2022-05-25

Mallinckrodt Pharmaceuticals Ireland Limitedcollege Business & Technology Parkcruiserath Roadblanchardstown D15 T PMA NumberP860003 Supplement NumberS107 Date Received04/27/2022 Decision Date05/25/2022 Product Code LNR Advisory Committee Gastroenterology/U...

THERAKOS CELLEX Photopheresis System (CELLEX), THERAKOS CELLEX Photopheresis Procedural Kit (CLXUSA and CLXECP), THERAKO

2022-03-11

Mallinckrodt Pharmaceuticals Ireland Limitedcollege Business & Technology Parkcruiserath Roadblanchardstown D15 T PMA NumberP860003 Supplement NumberS106 Date Received02/09/2022 Decision Date03/11/2022 Product Code LNR Advisory Committee Gastroenterology/U...