Mallinckrodt Manufacturing L L C FDA Filings

FDA Filings

Device Company	Device	Date
GUDID 10810055280152 Mallinckrodt Manufacturing LLC	INOmax	2024-04-08
GUDID 10810055280145 Mallinckrodt Manufacturing LLC	INOmax	2024-04-08
GUDID 10810055280138 Mallinckrodt Manufacturing LLC	INOmax	2024-04-08
GUDID 10810055280114 Mallinckrodt Manufacturing LLC	INOmax	2024-04-08
GUDID 10810055280107 Mallinckrodt Manufacturing LLC	INOmax	2024-04-08
GUDID 00810055280179 Mallinckrodt Manufacturing LLC	INOmax	2024-04-08
GUDID 00810055280162 Mallinckrodt Manufacturing LLC	INOmax	2024-04-08
GUDID 00810055280094 Mallinckrodt Manufacturing LLC	INOmax	2024-04-08
GUDID 00810055280087 Mallinckrodt Manufacturing LLC	INOmax	2024-04-08
GUDID 00810055280070 Mallinckrodt Manufacturing LLC	INOmax	2024-04-08
GUDID 00810055280063 Mallinckrodt Manufacturing LLC	INOmax	2024-04-08
GUDID 00810055280896 Mallinckrodt Manufacturing LLC	INOmax	2023-07-26
GUDID 10810055284174 Mallinckrodt Manufacturing LLC	INOmax	2023-05-18
GUDID 10810055283535 Mallinckrodt Manufacturing LLC	INOmax	2023-05-18
GUDID 10810055283504 Mallinckrodt Manufacturing LLC	INOmax	2023-05-18
GUDID 10810055283498 Mallinckrodt Manufacturing LLC	INOmax	2023-05-18
GUDID 10810055283467 Mallinckrodt Manufacturing LLC	INOmax	2023-05-18
GUDID 10810055283450 Mallinckrodt Manufacturing LLC	INOmax	2023-05-18
GUDID 10810055283436 Mallinckrodt Manufacturing LLC	INOmax	2023-05-18
GUDID 10810055281241 Mallinckrodt Manufacturing LLC	INOmax	2023-05-18
GUDID 10810055280923 Mallinckrodt Manufacturing LLC	INOmax	2023-05-18
GUDID 10810055280916 Mallinckrodt Manufacturing LLC	INOmax	2023-05-18
GUDID 10810055280909 Mallinckrodt Manufacturing LLC	INOmax	2023-05-18
GUDID 10810055280879 Mallinckrodt Manufacturing LLC	INOmax	2023-05-18
GUDID 10810055280862 Mallinckrodt Manufacturing LLC	INOmax	2023-05-18
GUDID 00810055288458 Mallinckrodt Manufacturing LLC	INOmax	2023-05-18
GUDID 00810055288441 Mallinckrodt Manufacturing LLC	INOmax	2023-05-18
GUDID 00810055283514 Mallinckrodt Manufacturing LLC	INOmax	2023-05-18
GUDID 00810055280988 Mallinckrodt Manufacturing LLC	INOmax	2023-05-18
GUDID 00810055280971 Mallinckrodt Manufacturing LLC	INOmax	2023-05-18
GUDID 00810055280964 Mallinckrodt Manufacturing LLC	INOmax	2023-05-18
GUDID 00810055280957 Mallinckrodt Manufacturing LLC	INOmax	2023-05-18
GUDID 00810055280940 Mallinckrodt Manufacturing LLC	INOmax	2023-05-18
GUDID 00810055280933 Mallinckrodt Manufacturing LLC	INOmax	2023-05-18
GUDID 00810055280193 Mallinckrodt Manufacturing LLC	INOmax	2023-05-18
GUDID 00810055280186 Mallinckrodt Manufacturing LLC	INOmax	2023-05-18
INOMAX INO THERAPEUTICS LLC, Mallinckrodt Manufacturing LLC	Prescription Medication	2023-04-15
GUDID 00810055285105 Mallinckrodt Manufacturing LLC	INOmax	2023-02-09
GUDID 00810055285099 Mallinckrodt Manufacturing LLC	INOmax	2023-02-09
GUDID 00810055285082 Mallinckrodt Manufacturing LLC	INOmax	2023-02-09
GUDID 00810055285075 Mallinckrodt Manufacturing LLC	INOmax	2023-02-09
GUDID 00810055285068 Mallinckrodt Manufacturing LLC	INOmax	2023-02-09
GUDID 00810055285051 Mallinckrodt Manufacturing LLC	INOmax	2023-02-09
GUDID 00810055285044 Mallinckrodt Manufacturing LLC	INOmax	2023-02-09
GUDID 00810055285037 Mallinckrodt Manufacturing LLC	INOmax	2023-02-09
GUDID 00810055285020 Mallinckrodt Manufacturing LLC	INOmax	2023-02-09
GUDID 00810055285013 Mallinckrodt Manufacturing LLC	INOmax	2023-02-09
GUDID 00810055285006 Mallinckrodt Manufacturing LLC	INOmax	2023-02-09
INOMAX INO THERAPEUTICS LLC, Mallinckrodt Manufacturing LLC	Prescription Medication	2023-01-26
GUDID 00810055280056 Mallinckrodt Manufacturing LLC	INOcal BOM-COM-0167	2022-07-26
GUDID 00810055280025 Mallinckrodt Manufacturing LLC	INOcal BOM-COM-0159	2022-07-26
GUDID 10810055280299 Mallinckrodt Manufacturing LLC	INOmax	2021-11-05
GUDID 10810055280268 Mallinckrodt Manufacturing LLC	INOmax	2021-11-05
GUDID 00810055280285 Mallinckrodt Manufacturing LLC	INOmax	2021-11-05
GUDID 00810055280278 Mallinckrodt Manufacturing LLC	INOmax	2021-11-05
GUDID 00810055280254 Mallinckrodt Manufacturing LLC	INOmax	2021-11-05
GUDID 10810055284280 Mallinckrodt Manufacturing LLC	INOmax	2021-08-16
GUDID 10810055284150 Mallinckrodt Manufacturing LLC	INOmax	2021-08-16
GUDID 10810055284037 Mallinckrodt Manufacturing LLC	INOmax	2021-08-16
GUDID 10810055284020 Mallinckrodt Manufacturing LLC	INOmax	2021-08-16
GUDID 10810055283528 Mallinckrodt Manufacturing LLC	INOmax	2021-08-16
GUDID 10810055283481 Mallinckrodt Manufacturing LLC	INOmax	2021-08-16
GUDID 10810055283474 Mallinckrodt Manufacturing LLC	INOmax	2021-08-16
GUDID 10810055283443 Mallinckrodt Manufacturing LLC	INOmax	2021-08-16
GUDID 10810055280886 Mallinckrodt Manufacturing LLC	INOmax	2021-08-16
INOMAX INO THERAPEUTICS LLC, Mallinckrodt Manufacturing LLC	Prescription Medication	2021-06-30
PMN K200389 Mallinckrodt Manufacturing LLC	INOmax DSIR Plus	2020-06-17
INOMAX INO THERAPEUTICS LLC, Mallinckrodt Manufacturing LLC	Prescription Medication	2019-02-26
GUDID 00867538000137 Mallinckrodt Manufacturing LLC	INOblender MRI	2018-07-06
GUDID 00867538000120 Mallinckrodt Manufacturing LLC	INOblender	2018-07-06
GUDID 00867538000113 Mallinckrodt Manufacturing LLC	INOmax DSIR Plus MRI	2018-07-06
GUDID 00867538000106 Mallinckrodt Manufacturing LLC	INOmax DSIR Plus	2018-07-06
PMN K843640 \| IYT Mallinckrodt Manufacturing LLC [Mallinckrodt Hospital Products IP Limited]	Xenotron I Xenon (Xe 133) Gas Dispenser	2016-07-18
BYX Mallinckrodt Manufacturing LLC [Mallinckrodt Hospital Products IP Limited]	Xenotron - Stopcock/Interconnect Accessory	2016-07-18
PMN K092545 \| MRQ Mallinckrodt Manufacturing LLC [Mallinckrodt Hospital Products IP Limited]	INOMAX DS DELIVERY SYSTEM	2016-07-06
PMN K092545 \| MRP Mallinckrodt Manufacturing LLC [Mallinckrodt Hospital Products IP Limited]	INOMAX DS DELIVERY SYSTEM	2016-07-06
PMN K092545 \| MRO Mallinckrodt Manufacturing LLC [Mallinckrodt Hospital Products IP Limited]	INOMAX DS DELIVERY SYSTEM	2016-07-06
PMN K092545 \| MRN Mallinckrodt Manufacturing LLC [Mallinckrodt Hospital Products IP Limited]	INOMAX DS DELIVERY SYSTEM	2016-07-06
PMN K143213 \| MRQ Mallinckrodt Manufacturing LLC [Mallinckrodt Hospital Products IP Limited]	INOmax DSIR Plus MRI (Delivery System)	2016-06-30
PMN K143213 \| MRP Mallinckrodt Manufacturing LLC [Mallinckrodt Hospital Products IP Limited]	INOmax DSIR Plus MRI (Delivery System)	2016-06-30
PMN K143213 \| MRO Mallinckrodt Manufacturing LLC [Mallinckrodt Hospital Products IP Limited]	INOmax DSIR Plus MRI (Delivery System)	2016-06-30
PMN K143213 \| MRN Mallinckrodt Manufacturing LLC [Mallinckrodt Hospital Products IP Limited]	INOmax DSIR Plus MRI (Delivery System)	2016-06-30
PMN K131686 \| MRQ Mallinckrodt Manufacturing LLC [Mallinckrodt Hospital Products IP Limited]	INOmax DSIR (Delivery System)	2016-06-30
PMN K131686 \| MRP Mallinckrodt Manufacturing LLC [Mallinckrodt Hospital Products IP Limited]	INOmax DSIR (Delivery System)	2016-06-30
PMN K131686 \| MRN Mallinckrodt Manufacturing LLC [Mallinckrodt Hospital Products IP Limited]	INOmax DSIR (Delivery System)	2016-06-30
PMN K130605 \| MRQ Mallinckrodt Manufacturing LLC [Mallinckrodt Hospital Products IP Limited]	INOmax DSIR (Delivery System)	2016-06-30
PMN K130605 \| MRP Mallinckrodt Manufacturing LLC [Mallinckrodt Hospital Products IP Limited]	INOmax DSIR (Delivery System)	2016-06-30
PMN K130605 \| MRN Mallinckrodt Manufacturing LLC [Mallinckrodt Hospital Products IP Limited]	INOmax DSIR (Delivery System)	2016-06-30
PMN K122689 \| MRO Mallinckrodt Manufacturing LLC [Mallinckrodt Hospital Products IP Limited]	INOblender	2016-06-30
PMN K121021 \| MRQ Mallinckrodt Manufacturing LLC [Mallinckrodt Hospital Products IP Limited]	INOmax DSIR (Delivery System)	2016-06-30
PMN K121021 \| MRP Mallinckrodt Manufacturing LLC [Mallinckrodt Hospital Products IP Limited]	INOmax DSIR (Delivery System)	2016-06-30
PMN K121021 \| MRN Mallinckrodt Manufacturing LLC [Mallinckrodt Hospital Products IP Limited]	INOmax DSIR (Delivery System)	2016-06-30
PMN K113272 \| MRP Mallinckrodt Manufacturing LLC [Mallinckrodt Hospital Products IP Limited]	INOmax DSIR (Delivery System)	2016-06-30
PMN K113272 \| MRN Mallinckrodt Manufacturing LLC [Mallinckrodt Hospital Products IP Limited]	INOmax DSIR (Delivery System)	2016-06-30
PMN K113272 \| MPQ Mallinckrodt Manufacturing LLC [Mallinckrodt Hospital Products IP Limited]	INOmax DSIR (Delivery System)	2016-06-30
PMN K110635 \| MRN Mallinckrodt Manufacturing LLC [Mallinckrodt Hospital Products IP Limited]	INOmax DSIR (Delivery System)	2016-06-30
PMN K110344 \| MRN Mallinckrodt Manufacturing LLC [Mallinckrodt Hospital Products IP Limited]	INOmax DSIR (Delivery System)	2016-06-30
PMN K093922 \| MRQ Mallinckrodt Manufacturing LLC [Mallinckrodt Hospital Products IP Limited]	INOmax DS (Delivery System)	2016-06-30
PMN K093922 \| MRP Mallinckrodt Manufacturing LLC [Mallinckrodt Hospital Products IP Limited]	INOmax DS (Delivery System)	2016-06-30
PMN K093922 \| MRO Mallinckrodt Manufacturing LLC [Mallinckrodt Hospital Products IP Limited]	INOmax DS (Delivery System)	2016-06-30
PMN K093922 \| MRN Mallinckrodt Manufacturing LLC [Mallinckrodt Hospital Products IP Limited]	INOmax DS (Delivery System)	2016-06-30
PMN K090958 \| MNR Mallinckrodt Manufacturing LLC [Mallinckrodt Hospital Products IP Limited]	INOmax DS (Delivery System)	2016-06-30
PMN K081691 \| MRQ Mallinckrodt Manufacturing LLC [Mallinckrodt Hospital Products IP Limited]	INOmax DS (Delivery System)	2016-06-30
PMN K081691 \| MRP Mallinckrodt Manufacturing LLC [Mallinckrodt Hospital Products IP Limited]	INOmax DS (Delivery System)	2016-06-30
PMN K081691 \| MRO Mallinckrodt Manufacturing LLC [Mallinckrodt Hospital Products IP Limited]	INOmax DS (Delivery System)	2016-06-30
PMN K081691 \| MRN Mallinckrodt Manufacturing LLC [Mallinckrodt Hospital Products IP Limited]	INOmax DS (Delivery System)	2016-06-30
PMN K080484 \| MRQ Mallinckrodt Manufacturing LLC [Mallinckrodt Hospital Products IP Limited]	INOmax DS (Delivery System)	2016-06-30
PMN K080484 \| MRP Mallinckrodt Manufacturing LLC [Mallinckrodt Hospital Products IP Limited]	INOmax DS (Delivery System)	2016-06-30
PMN K080484 \| MRO Mallinckrodt Manufacturing LLC [Mallinckrodt Hospital Products IP Limited]	INOmax DS (Delivery System)	2016-06-30
PMN K080484 \| MRN Mallinckrodt Manufacturing LLC [Mallinckrodt Hospital Products IP Limited]	INOmax DS (Delivery System)	2016-06-30
PMN K071516 \| MRN Mallinckrodt Manufacturing LLC [Mallinckrodt Hospital Products IP Limited]	INOmax DS (Delivery System)	2016-06-30
PMN K070867 \| MRQ Mallinckrodt Manufacturing LLC [Mallinckrodt Hospital Products IP Limited]	INOmax DS (Delivery System)	2016-06-30
PMN K070867 \| MRP Mallinckrodt Manufacturing LLC [Mallinckrodt Hospital Products IP Limited]	INOmax DS (Delivery System)	2016-06-30
PMN K070867 \| MRO Mallinckrodt Manufacturing LLC [Mallinckrodt Hospital Products IP Limited]	INOmax DS (Delivery System)	2016-06-30
PMN K070867 \| MRN Mallinckrodt Manufacturing LLC [Mallinckrodt Hospital Products IP Limited]	INOmax DS (Delivery System)	2016-06-30
BZO Mallinckrodt Manufacturing LLC [Mallinckrodt Hospital Products IP Limited]	Adapter , Gas Sample Tee	2016-05-23
BZO Mallinckrodt Manufacturing LLC [Mallinckrodt Hospital Products IP Limited]	Adapter , Cuff, 22 mm ID X 22 mm ID	2016-05-23
BZO Mallinckrodt Manufacturing LLC [Mallinckrodt Hospital Products IP Limited]	Adapter , 22M/15F X 22M/15F	2016-05-23
BZO Mallinckrodt Manufacturing LLC [Mallinckrodt Hospital Products IP Limited]	Adapter , 22F X 15M	2016-05-23
BZO Mallinckrodt Manufacturing LLC [Mallinckrodt Hospital Products IP Limited]	Adapter , 22 mm OD X 10 mm OD	2016-05-23
BZO Mallinckrodt Manufacturing LLC [Mallinckrodt Hospital Products IP Limited]	15M Adapter (fits 8.0 mm ID Tubing)	2016-05-23
BZO Mallinckrodt Manufacturing LLC [Mallinckrodt Hospital Products IP Limited]	15 M Adapter (fits 4.5 mm ID Tubing)	2016-05-23
PMN K061901 \| MRQ Mallinckrodt Manufacturing LLC [Mallinckrodt Hospital Products IP Limited]	INOMAX DS DELIVERY SYSTEM	2015-12-17
PMN K061901 \| MRP Mallinckrodt Manufacturing LLC [Mallinckrodt Hospital Products IP Limited]	INOMAX DS DELIVERY SYSTEM	2015-12-17
PMN K061901 \| MRO Mallinckrodt Manufacturing LLC [Mallinckrodt Hospital Products IP Limited]	INOMAX DS DELIVERY SYSTEM	2015-12-17
PMN K061901 \| MRN Mallinckrodt Manufacturing LLC [Mallinckrodt Hospital Products IP Limited]	INOMAX DS DELIVERY SYSTEM	2015-12-17
PMN K052663 \| MRO Mallinckrodt Manufacturing LLC [Mallinckrodt Hospital Products IP Limited]	INOBLENDER	2015-12-17
PMN K000186 \| MRQ Mallinckrodt Manufacturing LLC [Mallinckrodt Hospital Products IP Limited]	INOvent	2015-12-17
PMN K000186 \| MRP Mallinckrodt Manufacturing LLC [Mallinckrodt Hospital Products IP Limited]	INOvent	2015-12-17
PMN K000186 \| MRO Mallinckrodt Manufacturing LLC [Mallinckrodt Hospital Products IP Limited]	INOvent	2015-12-17
PMN K000186 \| MRN Mallinckrodt Manufacturing LLC [Mallinckrodt Hospital Products IP Limited]	INOvent	2015-12-17
BXK Mallinckrodt Manufacturing LLC [Mallinckrodt Hospital Products IP Limited]	INOcal Nitrogen Dioxide Calibration Gas	2015-12-17
BXK Mallinckrodt Manufacturing LLC [Mallinckrodt Hospital Products IP Limited]	INOcal Nitric Oxide Calibration Gas	2015-12-17

Registration Number	3009352626
FEI Number	2350054
Name	Mallinckrodt Manufacturing LLC
Owner & Operator	Mallinckrodt Hospital Products IP Limited
Contact Address	Damastown Industrial Estate Mulhuddart IE-D Dublin 15 IE
Registration Status	1
Initial Importer	N
Registration Expiration	2020-04-25
Registration Address	1060 Allendale Dr Port Allen, LA 70767 US
Establishment Type	Manufacture Medical Device

Registration Number	3004531588
FEI Number	3004531588
Name	Mallinckrodt Manufacturing LLC
Owner & Operator	Mallinckrodt Hospital Products IP Limited
Contact Address	Damastown Industrial Estate Mulhuddart IE-D Dublin 15 IE
Registration Status	1
Initial Importer	N
Registration Expiration	2020-04-25
Registration Address	6603 Femrite Dr MADISON, WI 53718 US
Establishment Type	Remanufacture Medical Device Manufacture Medical Device Manufacture Medical Device for Another Party (Contract Manufacturer)

Import ID	Shipment	Cargo Description	Quantity
2020062031566	London,United Kingdom -> Houston, Texas	UN1956 CLASS 2.2	20 PCS
2020061236673	London,United Kingdom -> Houston, Texas	UN1956 CLASS 2.2	20 PCS
2020012352	London,United Kingdom -> Houston, Texas	COMPRESSED GAS HAZ CL 2 UN 1956	1 PKG
2020011457	London,United Kingdom -> Houston, Texas	COMPRESSED GAS HAZ CL 2 UN 1956	1 PKG
2020011045150	London,United Kingdom -> Houston, Texas	GAS CYLINDERS HAZ CLASS 2.2	6 PCS
20200108104	London,United Kingdom -> Houston, Texas	COMPRESSED GAS HAZ CL 2 UN 1956	1 PKG
20200107334	London,United Kingdom -> Houston, Texas	COMPRESSED GAS HAZ CL 2 UN 1956	1 PKG
20191228237	London,United Kingdom -> Houston, Texas	COMPRESSED GAS HAZ CL 2 UN 1956	1 PKG