Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1219103

FEI Number

1000148701

Entity Name

Cardinal Health

City/State/Country

CHICOPEE, MA, US

Establishment Address

2 Ludlow Park Dr, CHICOPEE, MA 01022, US

Establishment Type(s)

Manufacture Device in the United States for Export Only,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

K973507

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
DRX	Electrode, Electrocardiograph	Cardiovascular	Class 2	870.2360	2014-12-04
KOI	Stimulator, Nerve, Peripheral, Electric	Anesthesiology	Class 2	868.2775	2018-08-09
NAE	Dressing, Wound, Hydrogel Without Drug And/Or Biologic	General, Plastic Surgery	Class 1	878.4022	2008-01-10
FXP	Cover, Shoe, Operating-Room	General, Plastic Surgery	Class 1	878.4040	1999-08-04
FRL	Fiber, Medical, Absorbent	General Hospital	Class 1	880.5300	1999-08-04
MGQ	Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic	Unknown	Class U	N/A	2008-01-10
LYY	Latex Patient Examination Glove	General Hospital	Class 1	880.6250	2008-01-11
MKJ	Automated External Defibrillators (Non-Wearable)	Cardiovascular	Class 3	870.5310	2013-08-08
MLN	Electrode, Electrocardiograph, Multi-Function	Cardiovascular	Class 2	870.2360	2013-08-08
MKJ	Automated External Defibrillators (Non-Wearable)	Cardiovascular	Class 3	870.5310	2016-03-10
DRO	Pacemaker, Cardiac, External Transcutaneous (Non-Invasive)	Cardiovascular	Class 2	870.5550	2004-06-01
MKJ	Automated External Defibrillators (Non-Wearable)	Cardiovascular	Class 3	870.5310	2024-11-11
NTC	Nursing Pad, Hydrogel	General Hospital	Class 1	880.5630	2014-11-06
DSF	Recorder, Paper Chart	Cardiovascular	Class 1	870.2810	1996-12-16
KPE	Container, I.V.	General Hospital	Class 2	880.5025	2008-01-11
MKJ	Automated External Defibrillators (Non-Wearable)	Cardiovascular	Class 3	870.5310	2018-09-18
PXG	Spill Kit	General Hospital	Class 1	880.6890	2018-06-06
OIB	Blood And Urine Collection Kit (Excludes Hiv Testing)	Pathology	Class 1	864.3250	2011-11-09
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2008-01-11
MLN	Electrode, Electrocardiograph, Multi-Function	Cardiovascular	Class 2	870.2360	2014-12-04
MKJ	Automated External Defibrillators (Non-Wearable)	Cardiovascular	Class 3	870.5310	2020-10-07
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2008-01-10

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

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
K934333	3M Medical Products Group	3M RED DOT 2237 STICKY GEL MONITORING ECG ELECTRODE	1994-07-07
K954741	Derma Sciences, Inc.	DERMAGRAN WENT DRESSING (DEXTROSE-SALINE)	1995-11-01
K894452	Kerala Rubber & Reclaims, Ltd.	KRR GLOVE, PATIENT EXAMINATION GLOVES	1989-08-09
K891323	Li Wah-Hong Kong, Inc.	LI WAH LATEX EXAMINATION GLOVES	1989-08-31
K891418	C & K Mfg. & Sales Co.	LATEX EXAMINATION GLOVES, STYLE 510 LX	1989-06-22

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0001-05	DeRoyal Wound Care	U	Aquasorb Border, Hydrogel Wound Dressing with Polyurethane Film Border, 25 individual packets per case, Catalog # 46-511, 2.5' x 2.5', labeled in part *SterileManufacturer: DeRoyal 200 Debusk Lane Powell, TN 37849 USA**
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.
Z-0005-06	Medtronic Emergency Response Systems, Inc.	3	Hard shell carry case for the LIFEPAK CR Plus.

Similar Registrations

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3003584029	Braemar Manufacturing, LLC	San Diego, CA, US
3017425211	LOHMANN PRECISION DIE CUTTING, LLC	Orange, VA, US
3008773647	CARDIONET, LLC	Phoenix, AZ, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1219103. Last updated year: 2026. Please use registration number 1219103 when referencing this establishment in official correspondence.