Mallinckrodt Manufacturing LLC

FDA Device Registration & Listing · Port Allen, LA, US · Registration 3009352626

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
3009352626
FEI Number
2350054
Entity Name
Mallinckrodt Manufacturing LLC
City/State/Country
Port Allen, LA, US
Establishment Address
1060 Allendale Dr, Port Allen, LA 70767, US
Establishment Type(s)
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
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

INOcal Nitrogen Dioxide Calibration Gas INOcal Nitric Oxide Calibration Gas

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
BXK Gas, Calibration (Specified Concentration) Anesthesiology Class 1 868.6400 2015-12-17

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
3004531588 Mallinckrodt Manufacturing LLC MADISON, WI, US

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009352626. Last updated year: 2026. Please use registration number 3009352626 when referencing this establishment in official correspondence.
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