MALLINCKRODT HOSPITAL PRODUCTS INC.

FDA Device Registration & Listing · Bridgewater, NJ, US · Registration 3014527933

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3014527933
FEI Number
3014074925
Entity Name
MALLINCKRODT HOSPITAL PRODUCTS INC.
City/State/Country
Bridgewater, NJ, US
Establishment Address
440 Route 22 East, Suite 302, Bridgewater, NJ 08807, US
Establishment Type(s)
Complaint File Establishment per 21 CFR 820.198
Owner / Operator
Mallinckrodt Hospital Products Inc. (Owner Number: 10057439)
Owner / Operator Contact Address
440 Route 22 East, Suite 302, Bridgewater, NJ 08807, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Therakos Cellex Photopheresis System INOmax DSIR Plus MRI (Delivery System) INOcal Nitric Oxide Calibration Gas INOcal Nitrogen Dioxide Calibration Gas

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
LNR System, Photopheresis, Extracorporeal Unknown Class 3 N/A 2018-04-05
MRP Analyzer, Nitric Oxide Anesthesiology Class 2 868.2380 2018-04-05
MRO Apparatus, Nitric Oxide, Backup Delivery Anesthesiology Class 2 868.5165 2018-04-05
MRN Apparatus, Nitric Oxide Delivery Anesthesiology Class 2 868.5165 2018-04-05
MRQ Analyzer, Nitrogen Dioxide Anesthesiology Class 2 868.2385 2018-04-05
BXK Gas, Calibration (Specified Concentration) Anesthesiology Class 1 868.6400 2026-03-19

Official Correspondent

Mark Wendelken

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Mallinckrodt Hospital Products Inc.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

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

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3014527933. Last updated year: 2026. Please use registration number 3014527933 when referencing this establishment in official correspondence.
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