FDA Registration
Active
🇺🇸 United States
Cardinal Health
Reg #: 1921846
·
FEI: 1921846
·
Expires 2026
Products
165
Proprietary Names
2
Establishment Types
1
Classifications
165
Registration Details
- Registration Name
- Cardinal Health
- Registration Number
- 1921846
- FEI Number
- 1921846
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 444 JAMES SOUTH MCDONNELL BLVD.
- City
- Hazelwood
- State
- MO
- ZIP
- 63042
- Country
- US
Regulatory Submissions
- 510(k) Number
- K771052
- PMA Number
- P190007
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 |
|---|---|---|---|---|---|
| Tubes, Vacuum Sample, With Anticoagulant | GIM | Class 2 | Clinical Chemistry | No | 2010-07-02 |
| Container, Sharps | MMK | Class 2 | General Hospital | No | 2007-11-30 |
| Continuous Measurement Thermometer | FLL | Class 2 | General Hospital | No | 2018-07-27 |
| Syringe, Piston | FMF | Class 2 | General Hospital | No | 2010-11-11 |
| Dressing, Wound, Drug | FRO | Class U | Unknown | No | 2013-05-03 |
| Device, Occlusion, Umbilical | FOD | Class 1 | General Hospital | No | 2024-06-10 |
| Fiber, Medical, Absorbent | FRL | Class 1 | General Hospital | No | 1999-08-04 |
| Pad, Neonatal Eye | FOK | Class 1 | General Hospital | No | 2006-05-26 |
| Gastrointestinal Tubes With Enteral Specific Connectors | PIF | Class 2 | Gastroenterology, Urology | No | 2022-05-25 |
| Tube, Double Lumen For Intestinal Decompression And/Or Intubation | FEG | Class 2 | Gastroenterology, Urology | No | 2022-05-25 |
| Stocking, Elastic | ILG | Class 1 | Physical Medicine | No | 2003-07-01 |
| Needle, Aspiration And Injection, Disposable | GAA | Class 1 | General, Plastic Surgery | No | 2005-04-13 |
| Surgeon'S Gloves | KGO | Class 1 | General, Plastic Surgery | No | 2020-01-31 |
| Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use | LXG | Class 1 | Clinical Chemistry | No | 2009-05-15 |
| Mask, Surgical | FXX | Class 2 | General, Plastic Surgery | No | 2006-04-11 |
| Enema Kit | FCE | Class 1 | Gastroenterology, Urology | No | 2002-02-23 |
| Negative Pressure Wound Therapy Powered Suction Pump | OMP | Class 2 | General, Plastic Surgery | No | 2021-09-21 |
| Clamp, Surgical, General & Plastic Surgery | GDJ | Class 1 | General, Plastic Surgery | No | 2007-04-26 |
| Tubes, Gastrointestinal (And Accessories) | KNT | Class 2 | Gastroenterology, Urology | No | 2018-07-27 |
| Introducer, Catheter | DYB | Class 2 | Cardiovascular | No | 2019-06-17 |
| Needle, Hypodermic, Single Lumen | FMI | Class 2 | General Hospital | No | 2007-12-03 |
| Syringe, Irrigating (Non Dental) | KYZ | Class 1 | General Hospital | No | 2003-08-05 |
| Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic | MGQ | Class U | Unknown | No | 2008-01-10 |
| Gauze / Sponge,Nonresorbable For External Use | NAB | Class 1 | General, Plastic Surgery | No | 2001-08-22 |
| Catheter, Urological | KOD | Class 2 | Gastroenterology, Urology | No | 2018-07-27 |
| Guide, Surgical, Instrument | FZX | Class 1 | General, Plastic Surgery | No | 2011-07-08 |
| Syringe, Balloon Inflation, Exempt | PTM | Class 2 | Cardiovascular | No | 2020-08-27 |
| Tubes, Vials, Systems, Serum Separators, Blood Collection | JKA | Class 2 | Clinical Chemistry | No | 2008-01-11 |
| Douche Apparatus, Vaginal, Therapeutic | HED | Class 1 | Obstetrics/Gynecology | No | 2002-02-23 |
| Bag, Ice | KYR | Class 1 | General Hospital | No | 2006-04-11 |
| Non-Surgical Gown | OEA | Class 1 | General, Plastic Surgery | No | 2009-09-23 |
| Catheter, Retention Type, Balloon | EZL | Class 2 | Gastroenterology, Urology | No | 2007-12-17 |
| Sleeve, Limb, Compressible | JOW | Class 2 | Cardiovascular | No | 2018-07-27 |
| Gown, Surgical | FYA | Class 2 | General, Plastic Surgery | No | 2008-04-15 |
| Mouthpiece, Saliva Ejector | DYN | Class 1 | Dental | No | 2004-06-03 |
| Pump, Infusion, Enteral | LZH | Class 2 | General Hospital | No | 2018-07-27 |
| Bandage, Liquid | KMF | Class 1 | General Hospital | No | 2008-01-10 |
| Dispenser, Liquid Medication | KYX | Class 1 | General Hospital | No | 1999-10-14 |
| Medical Glove, Specialty | LZC | Class 1 | General Hospital | No | 2016-05-23 |
| Dressing, Wound, Hydrogel Without Drug And/Or Biologic | NAE | Class 1 | General, Plastic Surgery | No | 2008-01-10 |
| Foley Catheter Kit (Excludes Hiv Testing) | PPB | Class 2 | Gastroenterology, Urology | No | 2018-04-20 |
| Binder, Abdominal | FSD | Class 1 | General Hospital | No | 1996-12-16 |
| Urinometer, Mechanical | EXR | Class 2 | Gastroenterology, Urology | No | 1993-01-14 |
| Container, Specimen, Sterile | FMH | Class 1 | Pathology | No | 2006-02-13 |
| Monitor, Pressure, Intrauterine | KXO | Class 2 | Obstetrics/Gynecology | No | 2006-09-22 |
| Clinical Electronic Thermometer | SDV | Class 2 | General Hospital | No | 2026-02-20 |
| Support, Patient Position | CCX | Class 1 | Anesthesiology | No | 2010-05-03 |
| Drape, Patient, Ophthalmic | HMT | Class 2 | General, Plastic Surgery | No | 2016-04-14 |
| Catheter, Urethral | GBM | Class 2 | Gastroenterology, Urology | No | 2007-12-17 |
| Catheter, Umbilical Artery | FOS | Class 2 | General Hospital | No | 2008-01-17 |
| General Surgery Tray | LRO | Class 2 | General, Plastic Surgery | No | 2021-08-16 |
| Electrode, Circular (Spiral), Scalp And Applicator | HGP | Class 2 | Obstetrics/Gynecology | No | 2008-01-11 |
| Polymer Patient Examination Glove | LZA | Class 1 | General Hospital | No | 2011-04-19 |
| Tube, Levine | FRQ | Class 2 | Gastroenterology, Urology | No | 2014-03-24 |
| System, Urine Drainage, Closed, For Nonindwelling Catheter, Sterile | EYZ | Class 1 | Gastroenterology, Urology | No | 2011-07-11 |
| Device, Biofeedback | HCC | Class 2 | Neurology | No | 2024-06-21 |
| Device, Urine Flow Rate Measuring, Non-Electrical, Disposable | FFG | Class 2 | Gastroenterology, Urology | No | 2002-02-23 |
| Collector, Urine, (And Accessories) For Indwelling Catheter | KNX | Class 2 | Gastroenterology, Urology | No | 2011-11-10 |
| Solvent, Adhesive Tape | KOX | Class 1 | General, Plastic Surgery | No | 2004-04-07 |
| Catheter, Straight | EZD | Class 2 | Gastroenterology, Urology | No | 2008-01-18 |
| Dressing, Wound, Hydrophilic | NAC | Class 1 | General, Plastic Surgery | No | 2013-03-26 |
| Container, I.V. | KPE | Class 2 | General Hospital | No | 2008-01-11 |
| Needle, Suturing, Disposable | GAB | Class 1 | General, Plastic Surgery | No | 2009-07-08 |
| Razor, Surgical | LWK | Class 1 | General, Plastic Surgery | No | 1999-02-12 |
| Gown, Non-Sterile, Non-Isolation, Intended To Provide Moderate Or High Barrier Protection | QPC | Class 2 | General, Plastic Surgery | No | 2019-04-29 |
| Clamp, Circumcision | HFX | Class 2 | Obstetrics/Gynecology | No | 2009-07-02 |
| Stand, Infusion | FOX | Class 1 | General Hospital | No | 1995-08-03 |
| Cap, Surgical | FYF | Class 1 | General, Plastic Surgery | No | 1990-01-03 |
| Drape, Surgical, Ent | ERY | Class 2 | General, Plastic Surgery | No | 2017-08-07 |
| Marker, Skin | FZZ | Class 1 | General, Plastic Surgery | No | 2009-06-15 |
| Pump, Infusion | FRN | Class 2 | General Hospital | No | 2018-07-27 |
| Needle, Dental | DZM | Class 1 | Dental | No | 1977-12-23 |
| Bottle, Collection, Vacuum | KDQ | Class 2 | General Hospital | No | 1995-08-01 |
| Tourniquet, Pneumatic | KCY | Class 1 | General, Plastic Surgery | No | 2021-08-16 |
| Container, Specimen Mailer And Storage, Sterile | KDT | Class 1 | Pathology | No | 2002-05-07 |
| Drape, Pure Latex Sheet, With Self-Retaining Finger Cot | EYX | Class 2 | General, Plastic Surgery | No | 2017-08-11 |
| Fentanyl And Other Opioid Protection Glove | QDO | Class 1 | General Hospital | No | 2026-02-10 |
| Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs | OPJ | Class 1 | General Hospital | No | 2026-02-10 |
| Catheters, Suction, Tracheobronchial | BSY | Class 1 | Anesthesiology | No | 1999-03-30 |
| Enteral Administration Kit (Adult & Pediatric) | PRM | Class 2 | Gastroenterology, Urology | No | 2018-08-09 |
| Device, Fixation, Tracheal Tube | CBH | Class 1 | Anesthesiology | No | 2025-08-12 |
| Brush, Scrub, Operating-Room | GEC | Class 1 | General, Plastic Surgery | No | 1995-08-02 |
| Enteral Syringes With Enteral Specific Connectors | PNR | Class 2 | Gastroenterology, Urology | No | 2016-07-25 |
| Automated External Defibrillators (Non-Wearable) | MKJ | Class 3 | Cardiovascular | No | 2009-09-03 |
| Accessory, Surgical Apparel | LYU | Class 1 | General, Plastic Surgery | No | 1994-05-23 |
| Tubing, Noninvasive | GAZ | Class 2 | General Hospital | No | 2007-04-26 |
| Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass | DWF | Class 2 | Cardiovascular | No | 2008-01-17 |
| Garment, Protective, For Incontinence | EYQ | Class 1 | Gastroenterology, Urology | No | 2013-06-03 |
| Basin, Emesis | FNY | Class 1 | General Hospital | No | 2002-05-07 |
| Drape, Urological, Disposable | EYY | Class 2 | General, Plastic Surgery | No | 2017-08-11 |
| Pad, Alcohol, Device Disinfectant | LKB | Class U | Unknown | No | 2008-01-10 |
| Gauze/Sponge, Internal | EFQ | Class U | Unknown | No | 2008-01-10 |
| Catheter (Gastric, Colonic, Etc.), Irrigation And Aspiration | KDH | Class 2 | Gastroenterology, Urology | No | 2018-07-27 |
| Connector, Catheter | GCD | Class 1 | General, Plastic Surgery | No | 2013-07-17 |
| Electrode, Electrocardiograph, Multi-Function | MLN | Class 2 | Cardiovascular | No | 2008-01-11 |
| Electrode, Cutaneous | GXY | Class 2 | Neurology | No | 2008-01-10 |
| Tubing, Pressure And Accessories | BYX | Class 1 | Anesthesiology | No | 2001-06-15 |
| Board, Arm (With Cover), Sterile | BTX | Class 1 | General, Plastic Surgery | No | 2004-03-22 |
| Tray, Surgical, Instrument | FSM | Class 1 | General, Plastic Surgery | No | 2006-05-12 |
| Laparoscope, General & Plastic Surgery | GCJ | Class 2 | Gastroenterology, Urology | No | 2008-06-20 |
| Gauze/Sponge, Internal, X-Ray Detectable | GDY | Class 1 | General, Plastic Surgery | No | 2005-07-11 |
| Lubricant, Patient | KMJ | Class 1 | General Hospital | No | 2013-12-03 |
| Drape, Microscope, Ophthalmic | HMW | Class 2 | General, Plastic Surgery | No | 2017-08-11 |
| Bandage, Elastic | FQM | Class 1 | General Hospital | No | 2007-04-26 |
| Labor And Delivery Kit | MLS | Class 2 | Obstetrics/Gynecology | No | 2008-06-17 |
| Trap, Sterile Specimen | BYZ | Class 2 | General Hospital | No | 2021-06-25 |
| Instrument, Biopsy | KNW | Class 2 | Gastroenterology, Urology | No | 2019-06-17 |
| Syringe, Periodontic, Endodontic, Irrigating | EIC | Class 1 | Dental | No | 1977-12-23 |
| Disinfectant, Medical Devices | LRJ | Class 1 | General Hospital | No | 2005-07-11 |
| Tubing, Fluid Delivery | FPK | Class 2 | General Hospital | No | 2008-01-28 |
| Bandage, Cast | ITG | Class 1 | Physical Medicine | No | 1999-08-04 |
| Catheter, Irrigation | GBX | Class 1 | General, Plastic Surgery | No | 1998-08-17 |
| Accessories, Catheter | KGZ | Class 1 | General, Plastic Surgery | No | 2021-08-17 |
| Catheter And Tip, Suction | JOL | Class 2 | General Hospital | No | 2007-04-26 |
| Tube, Aspirating, Flexible, Connecting | BYY | Class 2 | General Hospital | No | 1995-08-02 |
| Cannula, Surgical, General & Plastic Surgery | GEA | Class 1 | General, Plastic Surgery | No | 2005-04-06 |
| Gown, Isolation, Surgical | FYC | Class 2 | General, Plastic Surgery | No | 2016-07-29 |
| Lumbar Puncture Tray (Adult & Pediatric) | PWY | Class 2 | General Hospital | No | 2018-06-06 |
| Stimulator, Nerve, Transcutaneous, For Pain Relief | GZJ | Class 2 | Neurology | No | 2008-01-10 |
| Instrument, Surgical, Disposable | KDC | Class 1 | General, Plastic Surgery | No | 1994-02-02 |
| Tube, Tracheostomy (W/Wo Connector) | BTO | Class 2 | Anesthesiology | No | 2008-01-18 |
| Dressing, Wound, Occlusive | NAD | Class 1 | General, Plastic Surgery | No | 2006-03-20 |
| Peripheral Catheter Insertion Kit | OWL | Class 2 | General Hospital | No | 2011-11-11 |
| Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | FOZ | Class 2 | General Hospital | No | 2014-05-05 |
| Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days | LJS | Class 2 | General Hospital | No | 2014-05-05 |
| Electrode, Electrocardiograph | DRX | Class 2 | Cardiovascular | No | 2014-12-04 |
| Cable, Electrode | IKD | Class 2 | Physical Medicine | No | 2001-08-31 |
| Apparatus, Suction, Single Patient Use, Portable, Nonpowered | GCY | Class 1 | General, Plastic Surgery | No | 2000-08-03 |
| Tape And Bandage, Adhesive | KGX | Class 1 | General Hospital | No | 2001-07-27 |
| Wrap, Sterilization | FRG | Class 2 | General Hospital | No | 2018-12-19 |
| Holder, Needle, Gastroenterologic | FHQ | Class 1 | Gastroenterology, Urology | No | 2007-04-20 |
| Depressor, Tongue, Non-Surgical | FMA | Class 1 | General Hospital | No | 2026-06-12 |
| Tourniquet Kit | OJS | Class 1 | General, Plastic Surgery | No | 2011-11-11 |
| Syringe, Antistick | MEG | Class 2 | General Hospital | No | 2024-02-07 |
| Accessories, Catheter, G-U | KNY | Class 2 | Gastroenterology, Urology | No | 2008-01-18 |
| Pad, Eye | HMP | Class 1 | General, Plastic Surgery | No | 2001-07-26 |
| Instruments, Surgical, Cardiovascular | DWS | Class 1 | Cardiovascular | No | 2007-04-20 |
| Stocking, Medical Support (To Prevent Pooling Of Blood In Legs) | DWL | Class 2 | General Hospital | No | 2014-09-16 |
| Light, Surgical, Ceiling Mounted | FSY | Class 2 | General, Plastic Surgery | No | 2016-08-22 |
| Counter, Sponge, Surgical | LWH | Class 1 | General Hospital | No | 2019-10-23 |
| Ring (Wound Protector), Drape Retention, Internal | KGW | Class 2 | General, Plastic Surgery | No | 2017-08-11 |
| Manometer, Spinal-Fluid | FMJ | Class 2 | General Hospital | No | 2022-03-21 |
| Trocar | DRC | Class 2 | Cardiovascular | No | 2007-04-26 |
| Urinary Drainage Collection Kit, For Indwelling Catheter | FCN | Class 2 | Gastroenterology, Urology | No | 2011-07-11 |
| Tourniquet, Nonpneumatic | GAX | Class 1 | General, Plastic Surgery | No | 2009-06-25 |
| System, Blood Collection, Vacuum-Assisted, Manual | KST | Class 1 | Hematology | No | 2021-12-05 |
| Bedding, Disposable, Medical | KME | Class 1 | General Hospital | No | 2001-08-10 |
| Drape, Surgical, Exempt | PUI | Class 2 | General, Plastic Surgery | No | 2017-08-08 |
| Pack, Hot Or Cold, Reusable | IME | Class 1 | Physical Medicine | No | 1994-07-14 |
| Container, Specimen, Non-Sterile | NNI | Class 1 | Pathology | No | 2012-02-09 |
| Device, Incontinence, Urosheath Type, Sterile | EXJ | Class 1 | Gastroenterology, Urology | No | 2001-08-30 |
| Container, Liquid Medication, Graduated | KYW | Class 1 | General Hospital | No | 2002-05-07 |
| Bag, Urine Collection, Leg, For External Use, Sterile | FAQ | Class 1 | Gastroenterology, Urology | No | 1989-04-26 |
| Scalpel, One-Piece | GDX | Class 1 | General, Plastic Surgery | No | 2003-08-15 |
| Evacuator, Oral Cavity | EHZ | Class 1 | Dental | No | 2008-01-28 |
| Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit) | FCM | Class 2 | Gastroenterology, Urology | No | 2008-01-18 |
| Recorder, Paper Chart | DSF | Class 1 | Cardiovascular | No | 1996-12-16 |
| Bag, Intestine | KGY | Class 1 | General, Plastic Surgery | No | 2017-03-17 |
| Instrument, Manual, Surgical, General Use | MDM | Class 1 | General, Plastic Surgery | No | 2007-08-23 |
| Pacemaker, Cardiac, External Transcutaneous (Non-Invasive) | DRO | Class 2 | Cardiovascular | No | 2004-06-01 |
| Urinary Drainage Collection Kit | PPG | Class 2 | Gastroenterology, Urology | No | 2018-04-30 |
| Apparatus, Suction, Operating-Room, Wall Vacuum Powered | GCX | Class 2 | General Hospital | No | 2001-07-27 |
| Curette, Suction, Endometrial (And Accessories) | HHK | Class 2 | Obstetrics/Gynecology | No | 2008-06-11 |
| Cardiovascular Surgical Instruments Tray | OFA | Class 1 | Cardiovascular | No | 2009-05-07 |
| Board, Arm (With Cover), Non-Sterile | NOD | Class 1 | General, Plastic Surgery | No | 2024-05-29 |
Proprietary Names
CARDINAL HEALTH NITRILE EXAMINATION GLOVES EXTENDED CUFF
Stainless Steel Tongue Cleaner
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility