Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9612030

FEI Number

3002806934

Entity Name

Cardinal Health (Kenmex Medical Specialties)

City/State/Country

TIJUANA Baja California, MX

Establishment Address

CALLE 9 SUR 1113, CIUDAD INDUSTRIAL, TIJUANA Baja California 22444, MX

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
LWK	Razor, Surgical	General, Plastic Surgery	Class 1	878.4800	1999-02-12
PIF	Gastrointestinal Tubes With Enteral Specific Connectors	Gastroenterology, Urology	Class 2	876.5980	2015-08-06
EXR	Urinometer, Mechanical	Gastroenterology, Urology	Class 2	876.1800	1993-01-14
KGZ	Accessories, Catheter	General, Plastic Surgery	Class 1	878.4200	1999-08-04
FZZ	Marker, Skin	General, Plastic Surgery	Class 1	878.4660	2009-06-15
KNT	Tubes, Gastrointestinal (And Accessories)	Gastroenterology, Urology	Class 2	876.5980	2019-06-17
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2007-12-05
KNT	Tubes, Gastrointestinal (And Accessories)	Gastroenterology, Urology	Class 2	876.5980	2008-01-10
KOD	Catheter, Urological	Gastroenterology, Urology	Class 2	876.5130	2008-01-18
PPG	Urinary Drainage Collection Kit	Gastroenterology, Urology	Class 2	876.5130	2018-04-30
FSY	Light, Surgical, Ceiling Mounted	General, Plastic Surgery	Class 2	878.4580	2016-08-22
PUI	Drape, Surgical, Exempt	General, Plastic Surgery	Class 2	878.4370	2017-08-08
KMJ	Lubricant, Patient	General Hospital	Class 1	880.6375	2013-12-03
FCE	Enema Kit	Gastroenterology, Urology	Class 1	876.5210	2002-02-23
DRC	Trocar	Cardiovascular	Class 2	870.1390	2007-04-26
KYX	Dispenser, Liquid Medication	General Hospital	Class 1	880.6430	1999-10-14
HED	Douche Apparatus, Vaginal, Therapeutic	Obstetrics/Gynecology	Class 1	884.5900	2002-02-23
KNT	Tubes, Gastrointestinal (And Accessories)	Gastroenterology, Urology	Class 2	876.5980	2018-07-27
KNT	Tubes, Gastrointestinal (And Accessories)	Gastroenterology, Urology	Class 2	876.5980	2017-08-14
FEG	Tube, Double Lumen For Intestinal Decompression And/Or Intubation	Gastroenterology, Urology	Class 2	876.5980	2008-01-18
KNT	Tubes, Gastrointestinal (And Accessories)	Gastroenterology, Urology	Class 2	876.5980	2008-01-18
FSM	Tray, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2006-05-12
KDC	Instrument, Surgical, Disposable	General, Plastic Surgery	Class 1	878.4800	1994-02-02
LRJ	Disinfectant, Medical Devices	General Hospital	Class 1	880.6890	2005-07-11
KQS	Table, Cystometric, Non-Electric And Accessories	Gastroenterology, Urology	Class 1	876.4890	2012-11-07
JOL	Catheter And Tip, Suction	General Hospital	Class 2	880.6740	2007-04-26
KYZ	Syringe, Irrigating (Non Dental)	General Hospital	Class 1	880.6960	2003-08-05
FRN	Pump, Infusion	General Hospital	Class 2	880.5725	2018-07-27
PIF	Gastrointestinal Tubes With Enteral Specific Connectors	Gastroenterology, Urology	Class 2	876.5980	2019-12-11
FEG	Tube, Double Lumen For Intestinal Decompression And/Or Intubation	Gastroenterology, Urology	Class 2	876.5980	2019-12-11
PIF	Gastrointestinal Tubes With Enteral Specific Connectors	Gastroenterology, Urology	Class 2	876.5980	2022-05-25
FEG	Tube, Double Lumen For Intestinal Decompression And/Or Intubation	Gastroenterology, Urology	Class 2	876.5980	2022-05-25
HFX	Clamp, Circumcision	Obstetrics/Gynecology	Class 2	884.4530	2009-07-02
KOD	Catheter, Urological	Gastroenterology, Urology	Class 2	876.5130	2013-01-23
KNT	Tubes, Gastrointestinal (And Accessories)	Gastroenterology, Urology	Class 2	876.5980	2008-01-10
EYZ	System, Urine Drainage, Closed, For Nonindwelling Catheter, Sterile	Gastroenterology, Urology	Class 1	876.5250	2011-07-11
NNI	Container, Specimen, Non-Sterile	Pathology	Class 1	864.3250	2012-02-09
FEG	Tube, Double Lumen For Intestinal Decompression And/Or Intubation	Gastroenterology, Urology	Class 2	876.5980	2008-01-18
KNX	Collector, Urine, (And Accessories) For Indwelling Catheter	Gastroenterology, Urology	Class 2	876.5250	2011-11-10
LZH	Pump, Infusion, Enteral	General Hospital	Class 2	880.5725	2023-01-24
GAX	Tourniquet, Nonpneumatic	General, Plastic Surgery	Class 1	878.5900	2009-06-25
KNT	Tubes, Gastrointestinal (And Accessories)	Gastroenterology, Urology	Class 2	876.5980	2018-07-27
BTO	Tube, Tracheostomy (W/Wo Connector)	Anesthesiology	Class 2	868.5800	2008-01-18
LXG	Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use	Clinical Chemistry	Class 1	862.2050	2009-05-15
NXA	Tracheotomy Care Kit	Anesthesiology	Class 2	868.5800	2011-09-08
FFG	Device, Urine Flow Rate Measuring, Non-Electrical, Disposable	Gastroenterology, Urology	Class 2	876.1800	2002-02-23
FPK	Tubing, Fluid Delivery	General Hospital	Class 2	880.5440	2008-01-28
EZL	Catheter, Retention Type, Balloon	Gastroenterology, Urology	Class 2	876.5130	2008-01-18
GCY	Apparatus, Suction, Single Patient Use, Portable, Nonpowered	General, Plastic Surgery	Class 1	878.4680	2000-08-03
KYW	Container, Liquid Medication, Graduated	General Hospital	Class 1	880.6430	2002-05-07
LZH	Pump, Infusion, Enteral	General Hospital	Class 2	880.5725	2018-07-27
JOW	Sleeve, Limb, Compressible	Cardiovascular	Class 2	870.5800	2018-07-27
OJS	Tourniquet Kit	General, Plastic Surgery	Class 1	878.5900	2011-11-11
PIF	Gastrointestinal Tubes With Enteral Specific Connectors	Gastroenterology, Urology	Class 2	876.5980	2015-06-03
GBX	Catheter, Irrigation	General, Plastic Surgery	Class 1	878.4200	1998-08-17
KDD	Kit, Surgical Instrument, Disposable	General, Plastic Surgery	Class 1	878.4800	1996-05-01
PIO	Enteral Specific Transition Connectors	Gastroenterology, Urology	Class 2	876.5980	2015-06-10
KNT	Tubes, Gastrointestinal (And Accessories)	Gastroenterology, Urology	Class 2	876.5980	2016-10-28
EZL	Catheter, Retention Type, Balloon	Gastroenterology, Urology	Class 2	876.5130	2007-12-17
DWS	Instruments, Surgical, Cardiovascular	Cardiovascular	Class 1	870.4500	2007-04-20
PIF	Gastrointestinal Tubes With Enteral Specific Connectors	Gastroenterology, Urology	Class 2	876.5980	2018-12-11
KNT	Tubes, Gastrointestinal (And Accessories)	Gastroenterology, Urology	Class 2	876.5980	2018-12-11
HGP	Electrode, Circular (Spiral), Scalp And Applicator	Obstetrics/Gynecology	Class 2	884.2675	2008-01-11
KNY	Accessories, Catheter, G-U	Gastroenterology, Urology	Class 2	876.5130	2008-01-18
KOD	Catheter, Urological	Gastroenterology, Urology	Class 2	876.5130	2007-12-17
KNT	Tubes, Gastrointestinal (And Accessories)	Gastroenterology, Urology	Class 2	876.5980	2008-01-10
EZK	Catheter, Retention Type	Gastroenterology, Urology	Class 2	876.5980	2013-02-01
JOW	Sleeve, Limb, Compressible	Cardiovascular	Class 2	870.5800	2018-07-27
PRM	Enteral Administration Kit (Adult & Pediatric)	Gastroenterology, Urology	Class 2	876.5980	2018-08-09
DYN	Mouthpiece, Saliva Ejector	Dental	Class 1	872.6640	2004-06-03
BSY	Catheters, Suction, Tracheobronchial	Anesthesiology	Class 1	868.6810	1999-03-30
GEA	Cannula, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2005-04-06
PIF	Gastrointestinal Tubes With Enteral Specific Connectors	Gastroenterology, Urology	Class 2	876.5980	2017-01-20
FEG	Tube, Double Lumen For Intestinal Decompression And/Or Intubation	Gastroenterology, Urology	Class 2	876.5980	2017-01-20
EXJ	Device, Incontinence, Urosheath Type, Sterile	Gastroenterology, Urology	Class 1	876.5250	2001-08-30
FOZ	Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days	General Hospital	Class 2	880.5200	2023-02-02
KNT	Tubes, Gastrointestinal (And Accessories)	Gastroenterology, Urology	Class 2	876.5980	2019-01-25
PTM	Syringe, Balloon Inflation, Exempt	Cardiovascular	Class 2	870.1650	2020-08-27
KOD	Catheter, Urological	Gastroenterology, Urology	Class 2	876.5130	2018-07-27
GAZ	Tubing, Noninvasive	General Hospital	Class 2	880.6740	2007-04-26
FCM	Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit)	Gastroenterology, Urology	Class 2	876.5130	2008-01-18
KNT	Tubes, Gastrointestinal (And Accessories)	Gastroenterology, Urology	Class 2	876.5980	2008-01-10
LZH	Pump, Infusion, Enteral	General Hospital	Class 2	880.5725	2016-08-22
FCN	Urinary Drainage Collection Kit, For Indwelling Catheter	Gastroenterology, Urology	Class 2	876.5250	2011-07-11
KOD	Catheter, Urological	Gastroenterology, Urology	Class 2	876.5130	2018-05-22
LZH	Pump, Infusion, Enteral	General Hospital	Class 2	880.5725	2023-01-18
LZH	Pump, Infusion, Enteral	General Hospital	Class 2	880.5725	2018-07-27
MLS	Labor And Delivery Kit	Obstetrics/Gynecology	Class 2	884.4530	2008-06-17
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2008-01-28
EZL	Catheter, Retention Type, Balloon	Gastroenterology, Urology	Class 2	876.5130	2008-01-18
KNT	Tubes, Gastrointestinal (And Accessories)	Gastroenterology, Urology	Class 2	876.5980	2008-01-10
FRQ	Tube, Levine	Gastroenterology, Urology	Class 2	876.5980	2014-03-24

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
K900590	Biosearch Medical Products, Inc.	BIOSEARCH DOBBHOFF(R) GASTROTRAC JEJUNAL FEEDING	1990-08-02
K102548	Footprint Medical, Inc.	FOOTPRINT MEDICAL POLYURETHANE FEEDING TUBE	2010-11-26
K955248	United States Endoscopy Group, Inc.	U.S. ENDOSCOPY PULL PEG KIT & U.S. ENDOSCOPY GUIDEWIRE PEG KIT	1996-05-21
K872921	Medical Support, Inc.	MSS ENTERAL DELIVERY SET	1987-12-03
K180622	Covidien	Kangaroo Gastrostomy Feeding Tube with ENFit Y-Port	2018-10-23

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0003-04	Liberty Medical Supplies	2	Liberty brand Insulin Syringes for use with U-100 insulin, 1/2 cc X 30G X 5/16'' syringes
Z-0004-04	Liberty Medical Supplies	2	Liberty brand Insulin Syringes for use with U-100 insulin, 1 cc X 29G X 1/2 '' insulin syringes
Z-0005-04	Liberty Medical Supplies	2	Liberty brand Insulin Syringes for use with U-100 insulin, 1/2 cc X 29G X 1/2 '' insulin syringes
Z-0005-2024	Fresenius Medical Care Holdings, Inc.	2	10ML SYRINGE LUER LOCK W/OUT NEEDLE, Part Number 15-R010-0, 100 per box, 12 boxes to a case
Z-0006-2024	Fresenius Medical Care Holdings, Inc.	2	10ML SYRINGE LUER LOCK W/NEEDLE, Part Number 15-10ML-0, 100 per box, 12 boxes per case

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9612030. Last updated year: 2026. Please use registration number 9612030 when referencing this establishment in official correspondence.