Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9681860

FEI Number

3003491392

Entity Name

Ludlow Technical Products Canada, Ltd. (A Division of Cardinal Health LLC)

City/State/Country

GANANOQUE Ontario, CA

Establishment Address

215 Herbert St., GANANOQUE Ontario K7G 2Y7, CA

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

P190007

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
FSM	Tray, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2006-05-12
GWQ	Full-Montage Standard Electroencephalograph	Neurology	Class 2	882.1400	2019-05-09
GXY	Electrode, Cutaneous	Neurology	Class 2	882.1320	2019-05-09
MKJ	Automated External Defibrillators (Non-Wearable)	Cardiovascular	Class 3	870.5310	2009-09-03
BTX	Board, Arm (With Cover), Sterile	General, Plastic Surgery	Class 1	878.3910	2004-03-22
KXO	Monitor, Pressure, Intrauterine	Obstetrics/Gynecology	Class 2	884.2700	2006-09-22
HGP	Electrode, Circular (Spiral), Scalp And Applicator	Obstetrics/Gynecology	Class 2	884.2675	2008-01-11
FOK	Pad, Neonatal Eye	General Hospital	Class 1	880.5270	2006-05-26
KGX	Tape And Bandage, Adhesive	General Hospital	Class 1	880.5240	2001-07-27
FSD	Binder, Abdominal	General Hospital	Class 1	880.5160	1996-12-16
DRX	Electrode, Electrocardiograph	Cardiovascular	Class 2	870.2360	2014-12-04
MKJ	Automated External Defibrillators (Non-Wearable)	Cardiovascular	Class 3	870.5310	2020-11-17
GDJ	Clamp, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2007-04-26
DSB	Plethysmograph, Impedance	Cardiovascular	Class 2	870.2770	2012-04-04
MKJ	Automated External Defibrillators (Non-Wearable)	Cardiovascular	Class 3	870.5310	2019-01-03
MKJ	Automated External Defibrillators (Non-Wearable)	Cardiovascular	Class 3	870.5310	2020-10-07

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
9611018	Cardinal Health Ireland Manufacturing Limited	TULLAMORE Offaly, IE
8040459	Kendall-Gammatron Limited	SAMPRAN Nakhon Pathom, TH

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K070612	Top-Rank Health Care Equipment Co., Ltd.	TOP-RANK ADHESIVE ELECTRODE	2007-05-07
K123915	Grass Technologies, an Astro-Med, Inc. Product Gro	DE48-PLUS	2013-04-24
K073532	Technomed Europe	DISPOSABLE ADHESIVE SURFACE ELECTRODES, DISC ELECTRODES	2008-05-01
K260363	Ceribell, Inc.	Ceribell Brain Monitor Headband	2026-04-03
K091762	Covidien	DURA-STICK SELF-ADHESIVE ELECTRODES WITH ALOE	2009-12-22

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0027-2016	Zimmer, Inc.	1	Zimmer Universal Locking System, Titanium 3.5mm. Zimmer Implant and Instrument Cases are reusable, non-implantable devices designed to facilitate organization, identification, storage, transportation, cleaning, and sterilization processing of reusable instruments and certain unused implantable devices.
Z-0001-2008	Bio-Logic Systems Corp	2	Bio-logic System Corp --Telescoping Camera Pole Assembly (part number 585-CYBPSM and 580-VIDPOL) and assemblies (580IPCART and 580 PNCART; Bio-Logic Systems Corporation, Mundelein, IL 60060; The Model 580-VIDPOL is used with the 580-PNCART that is wired for use with a Panasonic Camera. The pole is also a subassembly of the 585-CYBPSM with wires used in the 580-IPCART wired for the use with an Ipela Camera. Both carts are a component of the Ceegraph/Sleepscan Netlink with Video.
Z-0003-2010	Philips Healthcare Inc.	3	HeartStart MRx (M3535A/M3536A) Defibrillator/Monitor. The HeartStart MRx/MRxE is for use for the termination of ventricular tachycardia and ventricular fibrillation. The device is for use by qualified medical personnel trained in the operation of the device and qualified by training basic life support, advanced cardiac support, or defibrillation. It must be used by or on the order of a physician.
Z-0004-06	Medtronic Emergency Response Systems, Inc.	3	Hard shell carry case for the LIFEPAK 500 AED.
Z-0004-2017	Leonhard Lang Medizintechnik GmbH Archenweg 56 Innsbruck Austria	3	Skintact Electrodes for Defibrillation, DF29N. Product Usage: Multifunction electrode for external defibrillation, pacing, cardioversion, and monitoring. The device is non-sterile and for single use only.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9681860. Last updated year: 2026. Please use registration number 9681860 when referencing this establishment in official correspondence.