FDA Registration
Active
🇲🇽 Mexico
Cardinal Health (Kenmex Medical Specialties)
Reg #: 9612030
·
FEI: 3002806934
·
Expires 2026
Products
74
Proprietary Names
0
Establishment Types
3
Classifications
73
Registration Details
- Registration Name
- Cardinal Health (Kenmex Medical Specialties)
- Registration Number
- 9612030
- FEI Number
- 3002806934
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- CALLE 9 SUR 1113, CIUDAD INDUSTRIAL
- City
- TIJUANA Baja California
- Country
- MX
Regulatory Submissions
- 510(k) Number
- K150084
Owner / Operator
- Firm Name
- Cardinal Health 200, LLC
- Operator Number
- 9028292
- Address
- 3651 Birchwood Drive, --
- City
- Waukegan
- State
- IL
- Postal Code
- 60085
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Razor, Surgical | LWK | Class 1 | General, Plastic Surgery | No | 1999-02-12 |
| Gastrointestinal Tubes With Enteral Specific Connectors | PIF | Class 2 | Gastroenterology, Urology | No | 2015-08-06 |
| Urinometer, Mechanical | EXR | Class 2 | Gastroenterology, Urology | No | 1993-01-14 |
| Accessories, Catheter | KGZ | Class 1 | General, Plastic Surgery | No | 1999-08-04 |
| Marker, Skin | FZZ | Class 1 | General, Plastic Surgery | No | 2009-06-15 |
| Tubes, Gastrointestinal (And Accessories) | KNT | Class 2 | Gastroenterology, Urology | No | 2019-06-17 |
| Syringe, Piston | FMF | Class 2 | General Hospital | No | 2007-12-05 |
| Catheter, Urological | KOD | Class 2 | Gastroenterology, Urology | No | 2008-01-18 |
| Urinary Drainage Collection Kit | PPG | Class 2 | Gastroenterology, Urology | No | 2018-04-30 |
| Light, Surgical, Ceiling Mounted | FSY | Class 2 | General, Plastic Surgery | No | 2016-08-22 |
| Drape, Surgical, Exempt | PUI | Class 2 | General, Plastic Surgery | No | 2017-08-08 |
| Lubricant, Patient | KMJ | Class 1 | General Hospital | No | 2013-12-03 |
| Enema Kit | FCE | Class 1 | Gastroenterology, Urology | No | 2002-02-23 |
| Trocar | DRC | Class 2 | Cardiovascular | No | 2007-04-26 |
| Dispenser, Liquid Medication | KYX | Class 1 | General Hospital | No | 1999-10-14 |
| Douche Apparatus, Vaginal, Therapeutic | HED | Class 1 | Obstetrics/Gynecology | No | 2002-02-23 |
| Tube, Double Lumen For Intestinal Decompression And/Or Intubation | FEG | Class 2 | Gastroenterology, Urology | No | 2008-01-18 |
| Tray, Surgical, Instrument | FSM | Class 1 | General, Plastic Surgery | No | 2006-05-12 |
| Instrument, Surgical, Disposable | KDC | Class 1 | General, Plastic Surgery | No | 1994-02-02 |
| Disinfectant, Medical Devices | LRJ | Class 1 | General Hospital | No | 2005-07-11 |
| Table, Cystometric, Non-Electric And Accessories | KQS | Class 1 | Gastroenterology, Urology | No | 2012-11-07 |
| Catheter And Tip, Suction | JOL | Class 2 | General Hospital | No | 2007-04-26 |
| Syringe, Irrigating (Non Dental) | KYZ | Class 1 | General Hospital | No | 2003-08-05 |
| Pump, Infusion | FRN | Class 2 | General Hospital | No | 2018-07-27 |
| Clamp, Circumcision | HFX | Class 2 | Obstetrics/Gynecology | No | 2009-07-02 |
| System, Urine Drainage, Closed, For Nonindwelling Catheter, Sterile | EYZ | Class 1 | Gastroenterology, Urology | No | 2011-07-11 |
| Container, Specimen, Non-Sterile | NNI | Class 1 | Pathology | No | 2012-02-09 |
| Collector, Urine, (And Accessories) For Indwelling Catheter | KNX | Class 2 | Gastroenterology, Urology | No | 2011-11-10 |
| Pump, Infusion, Enteral | LZH | Class 2 | General Hospital | No | 2023-01-24 |
| Tourniquet, Nonpneumatic | GAX | Class 1 | General, Plastic Surgery | No | 2009-06-25 |
| Tube, Tracheostomy (W/Wo Connector) | BTO | Class 2 | Anesthesiology | No | 2008-01-18 |
| Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use | LXG | Class 1 | Clinical Chemistry | No | 2009-05-15 |
| Tracheotomy Care Kit | NXA | Class 2 | Anesthesiology | No | 2011-09-08 |
| Device, Urine Flow Rate Measuring, Non-Electrical, Disposable | FFG | Class 2 | Gastroenterology, Urology | No | 2002-02-23 |
| Tubing, Fluid Delivery | FPK | Class 2 | General Hospital | No | 2008-01-28 |
| Catheter, Retention Type, Balloon | EZL | Class 2 | Gastroenterology, Urology | No | 2008-01-18 |
| Apparatus, Suction, Single Patient Use, Portable, Nonpowered | GCY | Class 1 | General, Plastic Surgery | No | 2000-08-03 |
| Container, Liquid Medication, Graduated | KYW | Class 1 | General Hospital | No | 2002-05-07 |
| Sleeve, Limb, Compressible | JOW | Class 2 | Cardiovascular | No | 2018-07-27 |
| Tourniquet Kit | OJS | Class 1 | General, Plastic Surgery | No | 2011-11-11 |
| Catheter, Irrigation | GBX | Class 1 | General, Plastic Surgery | No | 1998-08-17 |
| Kit, Surgical Instrument, Disposable | KDD | Class 1 | General, Plastic Surgery | No | 1996-05-01 |
| Enteral Specific Transition Connectors | PIO | Class 2 | Gastroenterology, Urology | No | 2015-06-10 |
| Instruments, Surgical, Cardiovascular | DWS | Class 1 | Cardiovascular | No | 2007-04-20 |
| Electrode, Circular (Spiral), Scalp And Applicator | HGP | Class 2 | Obstetrics/Gynecology | No | 2008-01-11 |
| Accessories, Catheter, G-U | KNY | Class 2 | Gastroenterology, Urology | No | 2008-01-18 |
| Catheter, Retention Type | EZK | Class 2 | Gastroenterology, Urology | No | 2013-02-01 |
| Enteral Administration Kit (Adult & Pediatric) | PRM | Class 2 | Gastroenterology, Urology | No | 2018-08-09 |
| Mouthpiece, Saliva Ejector | DYN | Class 1 | Dental | No | 2004-06-03 |
| Catheters, Suction, Tracheobronchial | BSY | Class 1 | Anesthesiology | No | 1999-03-30 |
| Cannula, Surgical, General & Plastic Surgery | GEA | Class 1 | General, Plastic Surgery | No | 2005-04-06 |
| Device, Incontinence, Urosheath Type, Sterile | EXJ | Class 1 | Gastroenterology, Urology | No | 2001-08-30 |
| Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | FOZ | Class 2 | General Hospital | No | 2023-02-02 |
| Syringe, Balloon Inflation, Exempt | PTM | Class 2 | Cardiovascular | No | 2020-08-27 |
| Tubing, Noninvasive | GAZ | Class 2 | General Hospital | No | 2007-04-26 |
| Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit) | FCM | Class 2 | Gastroenterology, Urology | No | 2008-01-18 |
| Urinary Drainage Collection Kit, For Indwelling Catheter | FCN | Class 2 | Gastroenterology, Urology | No | 2011-07-11 |
| Labor And Delivery Kit | MLS | Class 2 | Obstetrics/Gynecology | No | 2008-06-17 |
| Needle, Hypodermic, Single Lumen | FMI | Class 2 | General Hospital | No | 2008-01-28 |
| Tube, Levine | FRQ | Class 2 | Gastroenterology, Urology | No | 2014-03-24 |
| Laparoscope, General & Plastic Surgery | GCJ | Class 2 | Gastroenterology, Urology | No | 2008-06-20 |
| Container, Specimen, Sterile | FMH | Class 1 | Pathology | No | 2006-02-13 |
| Catheter, Straight | EZD | Class 2 | Gastroenterology, Urology | No | 2008-01-18 |
| Connector, Catheter | GCD | Class 1 | General, Plastic Surgery | No | 2013-07-17 |
| Enteral Syringes With Enteral Specific Connectors | PNR | Class 2 | Gastroenterology, Urology | No | 2016-07-25 |
| Instrument, Manual, Surgical, General Use | MDM | Class 1 | General, Plastic Surgery | No | 2007-08-23 |
| Needle, Suturing, Disposable | GAB | Class 1 | General, Plastic Surgery | No | 2009-07-08 |
| Tube, Aspirating, Flexible, Connecting | BYY | Class 2 | General Hospital | No | 1995-08-02 |
| Foley Catheter Kit (Excludes Hiv Testing) | PPB | Class 2 | Gastroenterology, Urology | No | 2018-04-20 |
| LDQ | No | 2012-01-27 | |||
| Catheter, Urethral | GBM | Class 2 | Gastroenterology, Urology | No | 2008-01-18 |
| Apparatus, Suction, Operating-Room, Wall Vacuum Powered | GCX | Class 2 | General Hospital | No | 2001-07-27 |
| Scalpel, One-Piece | GDX | Class 1 | General, Plastic Surgery | No | 2003-08-15 |
| Brush, Scrub, Operating-Room | GEC | Class 1 | General, Plastic Surgery | No | 1995-08-02 |
Establishment Types
Manufacture Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)
Repack or Relabel Medical Device