Data / Medical devices / Mexico / Cardinal Health (Kenmex Medical Specialties)

Cardinal Health (Kenmex Medical Specialties): FDA-registered device maker in TIJUANA Baja California, Mexico, 55 510(k) clearances

Name: Cardinal Health (Kenmex Medical Specialties) FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Cardinal Health (Kenmex Medical Specialties) is registered with the FDA (registration 9612030) in TIJUANA Baja California, Mexico. It lists 56 device types. The FDA files 55 510(k) clearances under its listings, the newest dated April 3, 2023. Registered through 2027. FDA data exported November 3, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Get makers like this one Watch Cardinal Health (Kenmex Medical Specialties)

FDA registration number: 9612030
FEI number: 3002806934
Address: Calle 9 Sur 1113 Ciudad Industrial, TIJUANA Baja California, Mexico, 22444
Owner or operator: Cardinal Health 200, LLC (9028292)
Roles: Manufacturer, Repackager or relabeler
First device listed: January 14, 1993
Registered through: 2027

Devices it lists

Device	Product code	Class	Role	Source
Accessories, Catheter	KGZ	1	Manufacturer	accessdata.fda.gov
Accessories, Catheter, G-U	KNY	2	Manufacturer	accessdata.fda.gov
Apparatus, Suction, Operating-Room, Wall Vacuum Powered	GCX	2	Manufacturer	accessdata.fda.gov
Apparatus, Suction, Single Patient Use, Portable, Nonpowered	GCY	1	Manufacturer	accessdata.fda.gov
Cannula, Surgical, General & Plastic Surgery	GEA	1	Manufacturer	accessdata.fda.gov
Catheter And Tip, Suction	JOL	2	Manufacturer	accessdata.fda.gov
Catheter, Retention Type, Balloon	EZL	2	Manufacturer	accessdata.fda.gov
Catheter, Straight	EZD	2	Manufacturer	accessdata.fda.gov
Catheter, Urethral	GBM	2	Manufacturer	accessdata.fda.gov
Catheter, Urological	KOD	2	Manufacturer	accessdata.fda.gov
Catheters, Suction, Tracheobronchial	BSY	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Collector, Urine, (And Accessories) For Indwelling Catheter	KNX	2	Manufacturer	accessdata.fda.gov
Connector, Catheter	GCD	1	Manufacturer	accessdata.fda.gov
Container, Specimen, Non-Sterile	NNI	1	Manufacturer	accessdata.fda.gov
Container, Specimen, Sterile	FMH	1	Manufacturer	accessdata.fda.gov
Device, Incontinence, Urosheath Type, Sterile	EXJ	1	Manufacturer	accessdata.fda.gov
Device, Intravascular Catheter Securement	KMK	1	Manufacturer	accessdata.fda.gov
Device, Urine Flow Rate Measuring, Non-Electrical, Disposable	FFG	2	Manufacturer	accessdata.fda.gov
Disinfectant, Medical Devices	LRJ	1	Manufacturer	accessdata.fda.gov
Dispenser, Liquid Medication	KYX	1	Manufacturer	accessdata.fda.gov
Douche Apparatus, Vaginal, Therapeutic	HED	1	Manufacturer	accessdata.fda.gov
Drape, Surgical, Exempt	PUI	2	Manufacturer	accessdata.fda.gov
Enema Kit	FCE	1	Manufacturer	accessdata.fda.gov
Enteral Administration Kit (Adult & Pediatric)	PRM	2	Manufacturer	accessdata.fda.gov
Enteral Specific Transition Connectors	PIO	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Enteral Syringes With Enteral Specific Connectors	PNR	2	Manufacturer	accessdata.fda.gov
Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use	LXG	1	Manufacturer	accessdata.fda.gov
Foley Catheter Kit (Excludes Hiv Testing)	PPB	2	Manufacturer	accessdata.fda.gov
Gastrointestinal Tubes With Enteral Specific Connectors	PIF	2	Manufacturer	accessdata.fda.gov
Instrument, Manual, Surgical, General Use	MDM	1	Manufacturer	accessdata.fda.gov
Instrument, Surgical, Disposable	KDC	1	Manufacturer	accessdata.fda.gov
Laparoscope, General & Plastic Surgery	GCJ	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Light, Surgical, Ceiling Mounted	FSY	2	Manufacturer	accessdata.fda.gov
Lubricant, Patient	KMJ	1	Manufacturer	accessdata.fda.gov
Marker, Skin	FZZ	1	Manufacturer	accessdata.fda.gov
Mouthpiece, Saliva Ejector	DYN	1	Manufacturer	accessdata.fda.gov
Needle, Hypodermic, Single Lumen	FMI	2	Manufacturer	accessdata.fda.gov
Needle, Suturing, Disposable	GAB	1	Manufacturer	accessdata.fda.gov
Pump, Infusion	FRN	2	Manufacturer	accessdata.fda.gov
Pump, Infusion, Enteral	LZH	2	Manufacturer	accessdata.fda.gov
Sleeve, Limb, Compressible	JOW	2	Manufacturer	accessdata.fda.gov
Syringe, Irrigating (Non Dental)	KYZ	1	Manufacturer	accessdata.fda.gov
Syringe, Piston	FMF	2	Manufacturer	accessdata.fda.gov
Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit)	FCM	2	Manufacturer	accessdata.fda.gov
Tray, Surgical, Instrument	FSM	1	Manufacturer	accessdata.fda.gov
Trocar	DRC	2	Manufacturer	accessdata.fda.gov
Tube, Aspirating, Flexible, Connecting	BYY	2	Manufacturer	accessdata.fda.gov
Tube, Double Lumen For Intestinal Decompression And/Or Intubation	FEG	2	Manufacturer	accessdata.fda.gov
Tube, Levine	FRQ	2	Manufacturer	accessdata.fda.gov
Tube, Tracheostomy (W/Wo Connector)	BTO	2	Manufacturer	accessdata.fda.gov
Tubes, Gastrointestinal (And Accessories)	KNT	2	Manufacturer	accessdata.fda.gov
Tubing, Fluid Delivery	FPK	2	Manufacturer	accessdata.fda.gov
Tubing, Noninvasive	GAZ	2	Manufacturer	accessdata.fda.gov
Urinary Drainage Collection Kit	PPG	2	Manufacturer	accessdata.fda.gov
Urinary Drainage Collection Kit, For Indwelling Catheter	FCN	2	Manufacturer	accessdata.fda.gov
Urinometer, Mechanical	EXR	2	Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
April 3, 2023	K230028	Kendall SCD SmartFlow Controller, Cardinal Health Element Sleeves, Kendall SCD Express Sleeves, Kendall SCD Express Foot Cuff, Kendall SCD Sequential Compression Comfort Sleeves, Kendall SCD SmartFlow Controller Tubing Assembly	JOW	Substantially Equivalent	Cardinal Health200, LLC	accessdata.fda.gov
December 20, 2022	K221603	Kangaroo OMNI Enteral Feeding Pump (385400 );Kangaroo OMNI Feeding Set 500ml (B5FD );Kangaroo OMNI ENtelliSet 500ml (E5FD );Kangaroo OMNI Feeding Set 1000ml (B10FD );Kangaroo OMNI ENtelliSet 1000ml (E10FD );Kangaroo OMNI ENPlus Spike Set (BSPFD );Kangaroo OMNI ENtelliSet ENPlus Spike ( ESPFD );Kangaroo OMNI Feeding Set 500ml with Flush Bag ( B5FF);Kangaroo OMNI ENtelliSet 500ml with Flush Bag (E5FF);Kangaroo OMNI Feeding Set 1000ml with Flush Bag ( E10FF );Kangaroo OMNI	LZH	Substantially Equivalent	Cardinal Health, LLC	accessdata.fda.gov
May 19, 2022	K213174	Salem Sump Silicone Dual Lumen Stomach Tube with ENFit Connection	PIF	Substantially Equivalent	Cardinalhealth	accessdata.fda.gov
November 7, 2019	K190923	Salem Sump Dual Lumen Stomach Tube with ENFit Connection	PIF	Substantially Equivalent	Cardinalhealth	accessdata.fda.gov
October 23, 2018	K180622	Kangaroo Gastrostomy Feeding Tube with ENFit Y-Port	KNT	Substantially Equivalent	Covidien	accessdata.fda.gov
July 6, 2016	K153074	Kangaroo Connect Enteral Feeding Pump with Kangaroo Connect Feeding Sets, Kangaroo Connect Portal	LZH	Substantially Equivalent	Covidien	accessdata.fda.gov
May 12, 2016	K160419	Monoject Enteral Feeding Syringe with ENFit Connector	PNR	Substantially Equivalent	Covidien	accessdata.fda.gov
October 8, 2015	K150711	Salem Sump Dual Lumen Stomach Tube with Multi-functional Port	PIF	Substantially Equivalent	Covidien	accessdata.fda.gov
July 13, 2015	K150084	Argyle¿ Polyvinyl Chloride (PVC) and Kangaroo¿ Polyurethane (PU) Neonatal and Pediatric Feeding Tubes with ENFit connector	PIF	Substantially Equivalent	Covidien	accessdata.fda.gov
May 29, 2015	K143263	Kangaroo Connect Enteral Feeding Pump with Kangaroo Connect Feeding Sets	LZH	Substantially Equivalent	Covidien	accessdata.fda.gov
April 2, 2015	K143018	Kangaroo Enteral Feeding Tube Extension Set with ENFit Small Bore Connectors	PIF	Substantially Equivalent	Covidien	accessdata.fda.gov
December 23, 2014	K141479	KANGAROO ENTERAL FEEDING SET WITH ENFIT CONNECTORS	LZH	Substantially Equivalent	Covidien	accessdata.fda.gov
October 17, 2014	K140581	CEDIC ENTERAL DISTAL END ENFIT TRANSITION CONNECTOR, CEDIC ENTERAL ENFIT TRANSITION CONNECTOR FOR MEDICATION PORT	PIO	Substantially Equivalent	Cedic S.R.L.	accessdata.fda.gov
May 11, 2012	K112511	DOBBHOFF DUAL PORT FEEDING TUBE	KNT	Substantially Equivalent	Covidien Lp, Formerly Registered AS Kendall	accessdata.fda.gov
October 16, 2007	K071049	DOVER 100% SILICONE FOLEY CATHETER WITH TEMPERATURE SENSOR	EZL	Substantially Equivalent	Tyco Healthcare	accessdata.fda.gov
January 18, 2005	K042709	DOVER SILVER TEMPERATURE SENSING FOLEY CATHETER	EZL	Substantially Equivalent	Tyco Healthcare	accessdata.fda.gov
July 20, 2004	K040897	DOVER ROB-NEL CATHETER	KOD	Substantially Equivalent	Tyco Healthcare	accessdata.fda.gov
June 28, 2004	K040511	SCD EXPRESS PORTABLE COMPRESSION SYSTEM	JOW	Substantially Equivalent	Tyco Healthcare/Kendall	accessdata.fda.gov
May 17, 2004	K040388	NEXT GENERATION SALEM SUMP	FEG	Substantially Equivalent	Kendall	accessdata.fda.gov
May 5, 2004	K040196	KENDALL EPUMP ENTERAL FEEDING PUMP AND ENTERAL FEEDING SETS	LZH	Substantially Equivalent	Tyco Healthcare/Kendall	accessdata.fda.gov
June 11, 2003	K024010	DOVER SILVER HYDROGEL COATED SILICONE FOLEY CATHETER	EZL	Substantially Equivalent	The Kendall Company Div. of Tyco Healthcare Group	accessdata.fda.gov
September 28, 1999	K990500	KENDALL ULTRAMER COUDE FOLEY CATHETER, MODEL 1416C, KENDALL CURITY COUDE FOLEY CATHETER TRAY, MODEL 6946C	EZL	Substantially Equivalent	The Kendal Co.	accessdata.fda.gov
February 27, 1998	K973409	KANGAROO ENTERAL FEEDING EXTENSION SET FOR SYRINGE PUMPS	KNT	Substantially Equivalent	Davis & Geck, Inc.	accessdata.fda.gov
November 7, 1997	K973546	KENDALL FAST-CATH PRE LUBRICATED URETHRAL CATHETER	EZD	Substantially Equivalent	Kendall Healthcare Products Co. Div.Of Tyco Health	accessdata.fda.gov
May 13, 1996	K960677	KANGAROO JEJUNAL FEEDING SYSTEM	KNT	Substantially Equivalent	Sherwood Medical Co.	accessdata.fda.gov
May 9, 1996	K960632	KANGAROO FEEDING TUBE PLACMENT STYLET	KNT	Substantially Equivalent	Sherwood Medical Co.	accessdata.fda.gov
March 8, 1996	K954429	KANGAROO ENTRISTAR SKIN-LEVEL GASTROSTOMY KIT	KNT	Unknown	Sherwood Medical Co.	accessdata.fda.gov
April 25, 1995	K951488	KENDALL CURITY CATHETER PLUG WITH PROTECTIVE CAP	KNY	Substantially Equivalent	The Kendal Co.	accessdata.fda.gov
March 7, 1995	K945964	KANGAROO(R) 524 ENTERAL FEEDING PUMP AND ADMINISTRATION SETS	LZH	Substantially Equivalent - Subject to Tracking Reg.	Sherwood Medical Co.	accessdata.fda.gov
March 1, 1995	K945715	MONOJECT(R) PISTON SYRINGES; 3,6,12,20,35 AND 60CC SIZES	FMF	Substantially Equivalent	Sherwood Medical Co.	accessdata.fda.gov
September 8, 1994	K932295	NON-BALLOON REPLACEMENT GASTROSTOMY KIT	KNT	Substantially Equivalent	Biosearch Medical Products, Inc.	accessdata.fda.gov
November 15, 1993	K933400	KENDALL CURITY 100% SILICONE FOLEY CATHETER W/TEMPERATURE SENSOR	KOD	Substantially Equivalent	Kendall Healthcare Products Co. Div.Of Tyco Health	accessdata.fda.gov
August 24, 1993	K933520	ENDOSCOPIC ANTI-FOG KIT, 100-302-00	GCJ	Substantially Equivalent	Avail-Southwest Division	accessdata.fda.gov
March 6, 1992	K914375	NON-WEIGHTED POLYURETHANE ENTERAL FEEDING TUBE	KNT	Substantially Equivalent	Sherwood Medical Co.	accessdata.fda.gov
January 15, 1992	K913784	DOBBHOFF(R) SINGLE PASS PEG KIT	KNT	Unknown	Biosearch Medical Products, Inc.	accessdata.fda.gov
October 8, 1991	K913914	PROGUARDII(TM) BLOOD COLLECTION DEVICE	FMI	Substantially Equivalent	Care Medical Devices, Inc.	accessdata.fda.gov
October 4, 1990	K903340	STERILE URETHRAL CATHETER PROCEDURE KITS	FCM	Unknown	Superior Healthcare Group, Inc.	accessdata.fda.gov
August 2, 1990	K900590	BIOSEARCH DOBBHOFF(R) GASTROTRAC JEJUNAL FEEDING	KNT	Substantially Equivalent	Biosearch Medical Products, Inc.	accessdata.fda.gov
August 2, 1990	K900563	DOBBHOFF(R) ENDOENTERIC GASTRIC DECOMPRESSION CATH	KNT	Substantially Equivalent	Biosearch Medical Products, Inc.	accessdata.fda.gov
June 23, 1989	K892442	KENDALL CURITY URETHRAL CATHETERS	GBM	Substantially Equivalent	The Kendal Co.	accessdata.fda.gov
May 26, 1988	K880850	KEITH NASOGASTRIC SUMP TUBE W/ANTI-REFLUX VALVE	FEG	Substantially Equivalent	Kmb Medical Products Co.	accessdata.fda.gov
August 6, 1987	K860688	MONOJECT PHARMACY TRAY	FMF	Substantially Equivalent	Sherwood Medical Co.	accessdata.fda.gov
March 11, 1986	K860484	CURITY & KENGUARD SILICONE COATED FOLEY CATHETER	KOD	Substantially Equivalent	The Kendal Co.	accessdata.fda.gov
June 12, 1985	K851539	CHESEBROUGH-PONDS KANGAROO PUMP SET W/EASY-CAP CLO	KNT	Substantially Equivalent	Chesebrough-Pond'S U.S.A. Co.	accessdata.fda.gov
May 10, 1985	K851444	KEITH-A.R.V.	KNT	Substantially Equivalent	Karl M. Block Co.	accessdata.fda.gov
November 28, 1983	K833621	ENTRI FLEX FEEDING TUBE	KNT	Substantially Equivalent	Biosearch Medical Products, Inc.	accessdata.fda.gov
July 12, 1983	K831868	DOBBHOFF FEEDING TUBE W/HYDROMER LUB	KNT	Substantially Equivalent	Biosearch Medical Products, Inc.	accessdata.fda.gov
March 10, 1982	K820442	ARGYLE INDWELL FEEDING TUBE	KNT	Substantially Equivalent	Sherwood Medical Co.	accessdata.fda.gov
March 10, 1982	K820441	ARGYLE PVC FEEDING TUBE	KNT	Substantially Equivalent	Sherwood Medical Co.	accessdata.fda.gov
March 31, 1981	K810630	SILICONE ELASTOMER COATED LATEX FOLEY	KOD	Substantially Equivalent	G.D. Searle and Co.	accessdata.fda.gov
March 2, 1981	K810156	ARGYLE SALEM SUMP TUBE	KNT	Substantially Equivalent	Sherwood Medical Co.	accessdata.fda.gov
February 9, 1981	K810216	ARGYLE ROB-NELS	KOD	Substantially Equivalent	Sherwood Medical Co.	accessdata.fda.gov
August 13, 1980	K801725	KANGAROO ENTERAL FEEDING PUMP	FRN	Substantially Equivalent	Chesebrough-Pond'S U.S.A. Co.	accessdata.fda.gov
February 14, 1978	K780062	CATHETER/HEMOSTATIC/GERIATRIC	EZL	Substantially Equivalent	Kendall Research Center	accessdata.fda.gov
December 16, 1976	K761190	TRACHEOSTOMY CARE KIT	BTO	Substantially Equivalent	Superior Plastic Products Corp.	accessdata.fda.gov

Compare with other makers

Updated April 3, 2023. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.