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
Tubes, Vacuum Sample, With Anticoagulant GIM
Container, Sharps MMK
Continuous Measurement Thermometer FLL
Syringe, Piston FMF
Dressing, Wound, Drug FRO
Device, Occlusion, Umbilical FOD
Fiber, Medical, Absorbent FRL
Pad, Neonatal Eye FOK
Gastrointestinal Tubes With Enteral Specific Connectors PIF
Tube, Double Lumen For Intestinal Decompression And/Or Intubation FEG
Stocking, Elastic ILG
Needle, Aspiration And Injection, Disposable GAA
Surgeon'S Gloves KGO
Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use LXG
Mask, Surgical FXX
Enema Kit FCE
Negative Pressure Wound Therapy Powered Suction Pump OMP
Clamp, Surgical, General & Plastic Surgery GDJ
Tubes, Gastrointestinal (And Accessories) KNT
Introducer, Catheter DYB
Needle, Hypodermic, Single Lumen FMI
Syringe, Irrigating (Non Dental) KYZ
Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic MGQ
Gauze / Sponge,Nonresorbable For External Use NAB
Catheter, Urological KOD
Guide, Surgical, Instrument FZX
Syringe, Balloon Inflation, Exempt PTM
Tubes, Vials, Systems, Serum Separators, Blood Collection JKA
Douche Apparatus, Vaginal, Therapeutic HED
Bag, Ice KYR
Non-Surgical Gown OEA
Catheter, Retention Type, Balloon EZL
Sleeve, Limb, Compressible JOW
Gown, Surgical FYA
Mouthpiece, Saliva Ejector DYN
Pump, Infusion, Enteral LZH
Bandage, Liquid KMF
Dispenser, Liquid Medication KYX
Medical Glove, Specialty LZC
Dressing, Wound, Hydrogel Without Drug And/Or Biologic NAE
Foley Catheter Kit (Excludes Hiv Testing) PPB
Binder, Abdominal FSD
Urinometer, Mechanical EXR
Container, Specimen, Sterile FMH
Monitor, Pressure, Intrauterine KXO
Clinical Electronic Thermometer SDV
Support, Patient Position CCX
Drape, Patient, Ophthalmic HMT
Catheter, Urethral GBM
Catheter, Umbilical Artery FOS
General Surgery Tray LRO
Electrode, Circular (Spiral), Scalp And Applicator HGP
Polymer Patient Examination Glove LZA
Tube, Levine FRQ
System, Urine Drainage, Closed, For Nonindwelling Catheter, Sterile EYZ
Device, Biofeedback HCC
Device, Urine Flow Rate Measuring, Non-Electrical, Disposable FFG
Collector, Urine, (And Accessories) For Indwelling Catheter KNX
Solvent, Adhesive Tape KOX
Catheter, Straight EZD
Dressing, Wound, Hydrophilic NAC
Container, I.V. KPE
Needle, Suturing, Disposable GAB
Razor, Surgical LWK
Gown, Non-Sterile, Non-Isolation, Intended To Provide Moderate Or High Barrier Protection QPC
Clamp, Circumcision HFX
Stand, Infusion FOX
Cap, Surgical FYF
Drape, Surgical, Ent ERY
Marker, Skin FZZ
Pump, Infusion FRN
Needle, Dental DZM
Bottle, Collection, Vacuum KDQ
Tourniquet, Pneumatic KCY
Container, Specimen Mailer And Storage, Sterile KDT
Drape, Pure Latex Sheet, With Self-Retaining Finger Cot EYX
Fentanyl And Other Opioid Protection Glove QDO
Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs OPJ
Catheters, Suction, Tracheobronchial BSY
Enteral Administration Kit (Adult & Pediatric) PRM
Device, Fixation, Tracheal Tube CBH
Brush, Scrub, Operating-Room GEC
Enteral Syringes With Enteral Specific Connectors PNR
Automated External Defibrillators (Non-Wearable) MKJ
Accessory, Surgical Apparel LYU
Tubing, Noninvasive GAZ
Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass DWF
Garment, Protective, For Incontinence EYQ
Basin, Emesis FNY
Drape, Urological, Disposable EYY
Pad, Alcohol, Device Disinfectant LKB
Gauze/Sponge, Internal EFQ
Catheter (Gastric, Colonic, Etc.), Irrigation And Aspiration KDH
Connector, Catheter GCD
Electrode, Electrocardiograph, Multi-Function MLN
Electrode, Cutaneous GXY
Tubing, Pressure And Accessories BYX
Board, Arm (With Cover), Sterile BTX
Tray, Surgical, Instrument FSM
Laparoscope, General & Plastic Surgery GCJ
Gauze/Sponge, Internal, X-Ray Detectable GDY
Lubricant, Patient KMJ
Drape, Microscope, Ophthalmic HMW
Bandage, Elastic FQM
Labor And Delivery Kit MLS
Trap, Sterile Specimen BYZ
Instrument, Biopsy KNW
Syringe, Periodontic, Endodontic, Irrigating EIC
Disinfectant, Medical Devices LRJ
Tubing, Fluid Delivery FPK
Bandage, Cast ITG
Catheter, Irrigation GBX
Accessories, Catheter KGZ
Catheter And Tip, Suction JOL
Tube, Aspirating, Flexible, Connecting BYY
Cannula, Surgical, General & Plastic Surgery GEA
Gown, Isolation, Surgical FYC
Lumbar Puncture Tray (Adult & Pediatric) PWY
Stimulator, Nerve, Transcutaneous, For Pain Relief GZJ
Instrument, Surgical, Disposable KDC
Tube, Tracheostomy (W/Wo Connector) BTO
Dressing, Wound, Occlusive NAD
Peripheral Catheter Insertion Kit OWL
Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days FOZ
Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days LJS
Electrode, Electrocardiograph DRX
Cable, Electrode IKD
Apparatus, Suction, Single Patient Use, Portable, Nonpowered GCY
Tape And Bandage, Adhesive KGX
Wrap, Sterilization FRG
Holder, Needle, Gastroenterologic FHQ
Depressor, Tongue, Non-Surgical FMA
Tourniquet Kit OJS
Syringe, Antistick MEG
Accessories, Catheter, G-U KNY
Pad, Eye HMP
Instruments, Surgical, Cardiovascular DWS
Stocking, Medical Support (To Prevent Pooling Of Blood In Legs) DWL
Light, Surgical, Ceiling Mounted FSY
Counter, Sponge, Surgical LWH
Ring (Wound Protector), Drape Retention, Internal KGW
Manometer, Spinal-Fluid FMJ
Trocar DRC
Urinary Drainage Collection Kit, For Indwelling Catheter FCN
Tourniquet, Nonpneumatic GAX
System, Blood Collection, Vacuum-Assisted, Manual KST
Bedding, Disposable, Medical KME
Drape, Surgical, Exempt PUI
Pack, Hot Or Cold, Reusable IME
Container, Specimen, Non-Sterile NNI
Device, Incontinence, Urosheath Type, Sterile EXJ
Container, Liquid Medication, Graduated KYW
Bag, Urine Collection, Leg, For External Use, Sterile FAQ
Scalpel, One-Piece GDX
Evacuator, Oral Cavity EHZ
Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit) FCM
Recorder, Paper Chart DSF
Bag, Intestine KGY
Instrument, Manual, Surgical, General Use MDM
Pacemaker, Cardiac, External Transcutaneous (Non-Invasive) DRO
Urinary Drainage Collection Kit PPG
Apparatus, Suction, Operating-Room, Wall Vacuum Powered GCX
Curette, Suction, Endometrial (And Accessories) HHK
Cardiovascular Surgical Instruments Tray OFA
Board, Arm (With Cover), Non-Sterile NOD

Proprietary Names

CARDINAL HEALTH NITRILE EXAMINATION GLOVES EXTENDED CUFF Stainless Steel Tongue Cleaner

Establishment Types

Develop Specifications But Do Not Manufacture At This Facility