Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9611018

FEI Number

3002808143

Entity Name

Cardinal Health Ireland Manufacturing Limited

City/State/Country

TULLAMORE Offaly, IE

Establishment Address

Tullamore Business and Technology Park, TULLAMORE Offaly R35 H903, IE

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Cardinal Health 200, LLC (Owner Number: 9028292)

Owner / Operator Contact Address

3651 Birchwood Drive, --, Waukegan, IL 60085, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

No proprietary names listed under this establishment.

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LZH	Pump, Infusion, Enteral	General Hospital	Class 2	880.5725	2018-07-27
LZH	Pump, Infusion, Enteral	General Hospital	Class 2	880.5725	2023-01-24
GCX	Apparatus, Suction, Operating-Room, Wall Vacuum Powered	General Hospital	Class 2	880.6740	2001-07-27
KDQ	Bottle, Collection, Vacuum	General Hospital	Class 2	880.6740	1995-08-01

Official Correspondent

No official correspondent registered.

US Agent Details

Stacey Henning Email: stacey.henning@cardinalhealth.com Phone: (312) 2702081

Related Public Records

Same Entity

Cardinal Health 200, LLC

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3004839227	Cardinal Health Malta 212 Ltd	Marsa, MT
3015541720	Cardinal Health Germany Manufacturing GmbH	Halberstadt Saxony-Anhalt, DE
1033903	Cardinal Health	Greenwood, SC, US
8040459	Kendall-Gammatron Limited	SAMPRAN Nakhon Pathom, TH
1623486	CARDINAL HEALTH 200, LLC	Jacksonville, TX, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K060316	Fresenius Kabi Deutschland GmbH	COMPAT GO ENTERAL FEEDING PUMP AND ADMINISTRATION SETS	2006-06-23

Similar Registrations

Registration Number	Establishment Name	Location
3005700264	Orbray (Thailand) Co. Ltd.	Muang Lamphun, TH
1423537	Cardinal Health 200, LLC	Waukegan, IL, US
9610849	Covidien	TIJUANA, B.C. Mexico, MX
3009211636	Cardinal Health Costa Rica, S.A.	-- Alajuela, CR
3012421607	MAINLINE MEDICAL DENTAL SUPPLY	North York Ontario, CA

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9611018. Last updated year: 2026. Please use registration number 9611018 when referencing this establishment in official correspondence.