Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3004531588

FEI Number

3004531588

Entity Name

Mallinckrodt Manufacturing LLC

City/State/Country

MADISON, WI, US

Establishment Address

6603 Femrite Dr, MADISON, WI 53718, US

Establishment Type(s)

Remanufacture Medical Device,Manufacture Medical Device

Owner / Operator

Mallinckrodt Hospital Products IP Limited (Owner Number: 10050702)

Owner / Operator Contact Address

Damastown Industrial Estate, Mulhuddart, IE-D 15, IE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K090958

PMA Number

N/A

All Registered Proprietary Names

Evolve Nitric Oxide Delivery System INOmax DSIR (Delivery System) INOmax DS (Delivery System) Xenotron I Xenon (Xe 133) Gas Dispenser INOmax DSIR (Delivery System) INOmax DSIR Plus INOMAX DS DELIVERY SYSTEM INOmax DSIR (Delivery System) INOvent INOmax DSIR (Delivery System) INOMAX DS DELIVERY SYSTEM INOmax DS (Delivery System) INOmax DS (Delivery System) Adapter , Gas Sample Tee 15M Adapter (fits 8 mm ID Tubing) Adapter , Cuff, 22 mm ID X 22 mm ID Adapter , 22F X 15M 15 M Adapter (fits 4.5 mm ID Tubing) Adapter , 22 mm OD X 10 mm OD Adapter , 22M/15F X 22M/15F Pediatric Extension, 15 mm, 6 inches One-Way Valve, 22F X 22M Sample Tee, O2 Tubing Adapter, 90 Degree Sample Port INOmax DSIR (Delivery System) INOmax DS (Delivery System) INOmax DSIR Plus MRI (Delivery System) INOmax DS (Delivery System) Xenotron - Stopcock/Interconnect Accessory INOblender INOmax DSIR (Delivery System) INOmax DS (Delivery System)

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MRN	Apparatus, Nitric Oxide Delivery	Anesthesiology	Class 2	868.5165	2023-12-15
MRP	Analyzer, Nitric Oxide	Anesthesiology	Class 2	868.2380	2023-12-15
MRQ	Analyzer, Nitrogen Dioxide	Anesthesiology	Class 2	868.2385	2023-12-15
MRP	Analyzer, Nitric Oxide	Anesthesiology	Class 2	868.2380	2016-06-30
MRN	Apparatus, Nitric Oxide Delivery	Anesthesiology	Class 2	868.5165	2016-06-30
MRQ	Analyzer, Nitrogen Dioxide	Anesthesiology	Class 2	868.2385	2016-06-30
MRN	Apparatus, Nitric Oxide Delivery	Anesthesiology	Class 2	868.5165	2016-06-30
IYT	System, Rebreathing, Radionuclide	Radiology	Class 2	892.1390	2016-07-18
MRN	Apparatus, Nitric Oxide Delivery	Anesthesiology	Class 2	868.5165	2016-06-30
MRN	Apparatus, Nitric Oxide Delivery	Anesthesiology	Class 2	868.5165	2025-08-06
MRP	Analyzer, Nitric Oxide	Anesthesiology	Class 2	868.2380	2025-08-06
MRQ	Analyzer, Nitrogen Dioxide	Anesthesiology	Class 2	868.2385	2025-08-06
MRQ	Analyzer, Nitrogen Dioxide	Anesthesiology	Class 2	868.2385	2016-07-06
MRP	Analyzer, Nitric Oxide	Anesthesiology	Class 2	868.2380	2016-07-06
MRN	Apparatus, Nitric Oxide Delivery	Anesthesiology	Class 2	868.5165	2016-07-06
MRO	Apparatus, Nitric Oxide, Backup Delivery	Anesthesiology	Class 2	868.5165	2016-07-06
MRP	Analyzer, Nitric Oxide	Anesthesiology	Class 2	868.2380	2016-06-30
MRQ	Analyzer, Nitrogen Dioxide	Anesthesiology	Class 2	868.2385	2016-06-30
MRN	Apparatus, Nitric Oxide Delivery	Anesthesiology	Class 2	868.5165	2016-06-30
MRP	Analyzer, Nitric Oxide	Anesthesiology	Class 2	868.2380	2015-12-17
MRQ	Analyzer, Nitrogen Dioxide	Anesthesiology	Class 2	868.2385	2015-12-17
MRO	Apparatus, Nitric Oxide, Backup Delivery	Anesthesiology	Class 2	868.5165	2015-12-17
MRN	Apparatus, Nitric Oxide Delivery	Anesthesiology	Class 2	868.5165	2015-12-17
MRN	Apparatus, Nitric Oxide Delivery	Anesthesiology	Class 2	868.5165	2016-06-30
MRP	Analyzer, Nitric Oxide	Anesthesiology	Class 2	868.2380	2016-06-30
MRQ	Analyzer, Nitrogen Dioxide	Anesthesiology	Class 2	868.2385	2016-06-30
MRN	Apparatus, Nitric Oxide Delivery	Anesthesiology	Class 2	868.5165	2015-12-17
MRO	Apparatus, Nitric Oxide, Backup Delivery	Anesthesiology	Class 2	868.5165	2015-12-17
MRP	Analyzer, Nitric Oxide	Anesthesiology	Class 2	868.2380	2015-12-17
MRQ	Analyzer, Nitrogen Dioxide	Anesthesiology	Class 2	868.2385	2015-12-17
MRQ	Analyzer, Nitrogen Dioxide	Anesthesiology	Class 2	868.2385	2016-06-30
MRO	Apparatus, Nitric Oxide, Backup Delivery	Anesthesiology	Class 2	868.5165	2016-06-30
MRP	Analyzer, Nitric Oxide	Anesthesiology	Class 2	868.2380	2016-06-30
MRN	Apparatus, Nitric Oxide Delivery	Anesthesiology	Class 2	868.5165	2016-06-30
MRP	Analyzer, Nitric Oxide	Anesthesiology	Class 2	868.2380	2016-06-30
MRQ	Analyzer, Nitrogen Dioxide	Anesthesiology	Class 2	868.2385	2016-06-30
MRO	Apparatus, Nitric Oxide, Backup Delivery	Anesthesiology	Class 2	868.5165	2016-06-30
MRN	Apparatus, Nitric Oxide Delivery	Anesthesiology	Class 2	868.5165	2016-06-30
BZO	Set, Tubing And Support, Ventilator (W Harness)	Anesthesiology	Class 1	868.5975	2016-05-23
MPQ	Container, Specimen, Urine, Drugs Of Abuse, Over The Counter	Pathology	Class 1	864.3260	2016-06-30
MRP	Analyzer, Nitric Oxide	Anesthesiology	Class 2	868.2380	2016-06-30
MRN	Apparatus, Nitric Oxide Delivery	Anesthesiology	Class 2	868.5165	2016-06-30
MRQ	Analyzer, Nitrogen Dioxide	Anesthesiology	Class 2	868.2385	2016-06-30
MRN	Apparatus, Nitric Oxide Delivery	Anesthesiology	Class 2	868.5165	2016-06-30
MRO	Apparatus, Nitric Oxide, Backup Delivery	Anesthesiology	Class 2	868.5165	2016-06-30
MRP	Analyzer, Nitric Oxide	Anesthesiology	Class 2	868.2380	2016-06-30
MRO	Apparatus, Nitric Oxide, Backup Delivery	Anesthesiology	Class 2	868.5165	2016-06-30
MRP	Analyzer, Nitric Oxide	Anesthesiology	Class 2	868.2380	2016-06-30
MRN	Apparatus, Nitric Oxide Delivery	Anesthesiology	Class 2	868.5165	2016-06-30
MRQ	Analyzer, Nitrogen Dioxide	Anesthesiology	Class 2	868.2385	2016-06-30
MRQ	Analyzer, Nitrogen Dioxide	Anesthesiology	Class 2	868.2385	2016-06-30
MRN	Apparatus, Nitric Oxide Delivery	Anesthesiology	Class 2	868.5165	2016-06-30
MRP	Analyzer, Nitric Oxide	Anesthesiology	Class 2	868.2380	2016-06-30
MRO	Apparatus, Nitric Oxide, Backup Delivery	Anesthesiology	Class 2	868.5165	2016-06-30
BYX	Tubing, Pressure And Accessories	Anesthesiology	Class 1	868.5860	2016-07-18
MRO	Apparatus, Nitric Oxide, Backup Delivery	Anesthesiology	Class 2	868.5165	2016-06-30
MRN	Apparatus, Nitric Oxide Delivery	Anesthesiology	Class 2	868.5165	2016-06-30
MNR	Ventilatory Effort Recorder	Anesthesiology	Class 2	868.2375	2016-06-30

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Mallinckrodt Hospital Products IP Limited

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3009352626	Mallinckrodt Manufacturing LLC	Port Allen, LA, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K082968	Apneicare, LLC	APNEICARE CONNECTION CENTER/INTERNET ANALYSIS	2009-01-02

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0028-2026	NOXBOX LTD	2	NOxBOXi Nitric Oxide Delivery System; Model Numbers: NOXBOX-I
Z-0029-2026	NOXBOX LTD	2	NOxBOXi Nitric Oxide Delivery System; Model Numbers: NOXBOX-I
Z-0031-2026	Percussionaire Corporation	1	Phasitron 5, IPV In-Line Valve, (Intrapulmonary Percussive Ventilation) REF: P5-TEE-20 (pack of 20)/ P5-TEE (individual) with In-Line Valve Sentec Instructions for Use
Z-0031-2022	NOX MEDICAL Keldnaholt Reykjavik Iceland	2	Nox T3s Recorder - Product Usage: intended for ambulatory recording of physiological signals during sleep.

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3014527933	MALLINCKRODT HOSPITAL PRODUCTS INC.	Bridgewater, NJ, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004531588. Last updated year: 2026. Please use registration number 3004531588 when referencing this establishment in official correspondence.