FDA Registration Active 🇺🇸 United States

Cardinal Health 200, LLC

Reg #: 1423537 · FEI: 3001236905 · Expires 2026
Products
492
Proprietary Names
2
Establishment Types
1
Classifications
491

Registration Details

Registration Name
Cardinal Health 200, LLC
Registration Number
1423537
FEI Number
3001236905
Status
Active
Expiry Year
2026
Initial Importer
Yes
Address
3651 Birchwood Drive
City
Waukegan
State
IL
ZIP
60085
Country
US

Regulatory Submissions

510(k) Number
K153074
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
Gastrointestinal Tube Kit PRW
Table, Surgical With Orthopedic Accessories, Manual JEB
Penile Implant Surgical Accessories QGA
Hemodialysis Tray (Not A Start/Stop Kit) PPI
Airway Suction Kit OFO
Container, Liquid Medication, Graduated KYW
Urinary Drainage Collection Kit PPG
Pump, Infusion, Enteral LZH
Balloon Gastrostomy Tube Kit PRP
Winged Intravenous Catheterization Kit OFN
Syringe, Piston FMF
Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days FOZ
Endometrial Sampling Kit OKZ
Sleeve, Limb, Compressible JOW
Blood/Plasma Collection Device For Dna Testing PJE
Speculum, Vaginal, Nonmetal HIB
Cover, Limb IPM
Syringe, Periodontic, Endodontic, Irrigating EIC
Tubes, Vials, Systems, Serum Separators, Blood Collection JKA
Catheter, Umbilical Artery FOS
Gynecological Laparoscopic Kit OHD
Personal Protection Kit PXC
Enteral Administration Kit (Adult & Pediatric) PRM
Tubes, Gastrointestinal (And Accessories) KNT
Spatula, Cervical, Cytological HHT
Drape, Surgical, Ent ERY
Laceration Tray PKD
Myringotomy Procedure Kit OGS
Operating Room Accessories Table Tray FWZ
Catheter, Urological KOD
Electrosurgical, Cutting & Coagulation & Accessories GEI
Breast Biopsy / Localization Tray PXP
Razor, Surgical LWK
Vasovasostomy Set PVY
Needle, Suturing, Disposable GAB
Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs OPJ
Medical Glove, Specialty LZC
Polymer Patient Examination Glove LZA
Oral Irrigation Kit OGT
Bag, Intestine KGY
Device, Urine Flow Rate Measuring, Non-Electrical, Disposable FFG
Suture, Nonabsorbable, Synthetic, Polypropylene GAW
Suture Removal Kit MCZ
Scalpel, One-Piece GDX
Instruments, Surgical, Cardiovascular DWS
Transducer, Blood-Pressure, Extravascular DRS
Tube, Tracheostomy (W/Wo Connector) BTO
Garment, Protective, For Incontinence EYQ
Arterial Blood Sampling Kit CBT
Continuous Brachial Plexus Block Tray OGC
Cardiac Catheterization Kit OES
Sitz Bath Kit PXF
Device, Patient Transfer, Powered FRZ
Orotracheal Intubation Guide Kit OGK
Oxygen Administration Kit OGL
Body Fluid Clean Up Kit OKG
Anesthesia Breathing Circuit Kit (Adult & Pediatric) OFP
Container, Sharps MMK
Catheter, Retention Type, Balloon EZL
Pap Smear Kit OHL
Surgeon'S Gloves KGO
Catheter, Cholangiography GBZ
Set, Administration, Intravascular FPA
Sampler, Amniotic Fluid (Amniocentesis Tray) HIO
Dental Hygiene Kit NXZ
Cap, Surgical FYF
Gauze/Sponge, Internal EFQ
Electrode, Cutaneous GXY
Dish, Tissue Culture KIZ
Scissors, Ophthalmic HNF
Spinal Epidural Anesthesia Kit OFT
Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass DWF
Catheters, Suction, Tracheobronchial BSY
Collector, Urine, (And Accessories) For Indwelling Catheter KNX
Collector, Ostomy EXB
Dispenser, Liquid Medication KYX
General Purpose Instrument Tray PXV
Culdocentesis Kit OHF
Mask, Surgical FXX
Incision Tray PXX
Percutaneous Sheath Introducer Kit OFL
Brush, Scrub, Operating-Room GEC
First Aid Kit Without Drug OHO
Device, Occlusion, Umbilical FOD
Blade, Scalpel GES
Drape, Microscope, Ophthalmic HMW
Herniorraphy Kit PXW
Clamp, Vascular DXC
Caudal Anesthesia Kit OGB
Needle, Hypodermic, Single Lumen FMI
Latex Patient Examination Glove LYY
Wrap, Sterilization FRG
Cover, Shoe, Operating-Room FXP
Breast Pump Kit OHH
Catheter, Urethral GBM
Nasogastric-Gastrojejunal Kit PSC
Nerve Block Tray OGJ
Stopcock, I.V. Set FMG
Tray, Surgical, Instrument FSM
Catheter, Upper Urinary Tract EYC
Suture, Absorbable, Synthetic, Polyglycolic Acid GAM
Suture, Nonabsorbable, Synthetic, Polyethylene GAT
Suture, Nonabsorbable, Silk GAP
Suture, Absorbable, Natural GAL
Suture, Nonabsorbable, Synthetic, Polyamide GAR
Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile GAQ
Admission Kit (Patient Utensil) PWM
Parenteral Administration Kit POR
Protector, Skin Pressure FMP
Enema Kit FCE
Ostomy Care Kit PQE
Wire, Guide, Catheter DQX
Fixture Mount Kit NYE
Transtibial Anterior Cruciate Ligament Kit PPQ
Cardiopulmonary Resuscitation Aid Kit OEV
General Surgery Tray LRO
Neurological Tray OJG
Component, Traction, Non-Invasive KQZ
Basin, Emesis FNY
Tracheotomy Care Kit NXA
Fetal Blood Sampling Kit (Excludes Hiv Testing) PVS
Spill Kit PXG
Endoscopic Cholangiogram Kit NWT
Gastrointestinal Tubes With Enteral Specific Connectors PIF
Holder, Needle; Orthopedic HXK
Denture Repair Kit EBO
Percutaneous Endoscopic Gastrostomy Kit PSG
Seminal Fluid Collection Kit OKW
Skin Prep Tray OJU
Dialysis Administration Kit PEV
Paracervical Anesthesia Kit PVV
Intravenous Extension Tubing Set OJA
Negative Pressure Wound Therapy Powered Suction Pump OMP
Ct Biopsy Tray OFG
Laparoscopic Cholecystectomy Kit PKE
Dressing, Wound, Drug FRO
Kit, Screening, Urine JXA
D And C Tray PKF
Tubing, Pressure And Accessories BYX
Syringe, Antistick MEG
Suture, Nonabsorbable GAO
Enteral Specific Transition Connectors PIO
Shave Prep Kit OJW
Restorative Instrument And Component Tray OFW
Tracheostomy Cleaning Tray OGV
Endoscopic Ventricular Catheter Placement Kit PVM
Toothbrush, Manual EFW
Continuous Measurement Thermometer FLL
Paracentesis Tray PYC
Fentanyl And Other Opioid Protection Glove QDO
Peritoneal Dialysis Tubing Kit PPK
Curette, Suction, Endometrial (And Accessories) HHK
Counter, Sponge, Surgical LWH
Pad, Alcohol, Device Disinfectant LKB
Gauze/Sponge, Internal, X-Ray Detectable GDY
Gastric Irrigation And Aspiration Kit PRT
Tubes, Vacuum Sample, With Anticoagulant GIM
Ulcer Wound Tray PYJ
Device, Incontinence, Urosheath Type, Sterile EXJ
Obstetrical Vacuum Delivery Kit OHC
Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase CCK
Bag, Urine Collection, Leg, For External Use, Sterile FAQ
Replacement Gastrostomy Feeding Catheter Tray PSK
Cutter, Wire HXZ
Bandage, Liquid KMF
Snake Bite Suction Kit KYP
Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days LJS
Tube, Double Lumen For Intestinal Decompression And/Or Intubation FEG
Enteral Syringes With Enteral Specific Connectors PNR
Container, Specimen Mailer And Storage, Sterile KDT
Binder, Abdominal FSD
Holder, Needle, Gastroenterologic FHQ
Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic MGQ
Scissors, Wire Cutting, Ent, Sterile JYA
Tube, Aspirating, Flexible, Connecting BYY
Umbilical Catheter Insertion Tray PXJ
Burn Dressing Tray PXQ
Mouthpiece, Saliva Ejector DYN
Blood Specimen Collection Kit (Excludes Hiv Testing) OFZ
Hysterectomy Kit OJF
Bone Marrow Collection/Transfusion Kit LWE
Scissors, General, Surgical LRW
Clean-Up Kit PWU
Gastric Lavage Kit (Adult Or Pediatric Use) PRU
Bone Marrow Biopsy Tray PXO
Accessories, Catheter KGZ
Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass DTL
Foley Catheter Kit (Excludes Hiv Testing) PPB
Catheter And Tip, Suction JOL
Kidney Perfusion Kit PIN
Clinical Electronic Thermometer SDV
Trap, Sterile Specimen BYZ
Humidifier Nebulizer Kit OGG
Blood Transfusion Kit POQ
Clamp, Circumcision HFX
Handle, Scalpel GDZ
Biopsy Needle Kit POZ
Catheter, Irrigation GBX
Hemostat HRQ
Guide, Surgical, Instrument FZX
Needle, Spinal, Short Term MIA
Speculum, Vaginal, Metal HDF
Pack, Hot Or Cold, Reusable IME
Central Venous Catheter Tray OFF
Automated External Defibrillators (Non-Wearable) MKJ
Staple Removal Kit PYE
Dilator, Rectal FFP
Oximeter DQA
Esophageal Dilator Kit PRQ
Neonatal Blood Collection Kit And Screening Form (Excludes Hiv Testing) OIA
Staple, Removable (Skin) GDT
Custom Anesthesia Tray OGD
Device, Fixation, Tracheal Tube CBH
Central Venous Blood Pressure Kit OFE
Bag, Ice KYR
Forceps, Ent KAE
Douche Apparatus, Vaginal, Therapeutic HED
Syringe, Irrigating (Non Dental) KYZ
Gown, Surgical FYA
Tracheostomy And Nasal Suctioning Kit LRQ
Mesh, Surgical, Polymeric FTL
Intracranial Pressure & Temperature Monitoring Kit PSP
Pad, Neonatal Eye FOK
Decontamination Kit MAC
Laparoscopic Bone Anchor Urethropexy Instrument Kit NWN
Pierced Ear/Entry Cleaning Tray OGU
Body Fluid Disposal Kit OKF
Instrument, Biopsy KNW
Vascular Access Port Kit PXK
Digital Angiography Tray OFH
Cardiopulmonary Bypass Catheter Kit OEU
Monitor, Pressure, Intrauterine KXO
Probe HXB
Slides, Microscope KEW
Tray, Surgical LRP
Catheter, Ventricular, General & Plastic Surgery GBS
Tubing, Fluid Delivery FPK
Needle, Dental DZM
Cannula, Surgical, General & Plastic Surgery GEA
Board, Arm (With Cover), Non-Sterile NOD
Cardiovascular Catheter Sheath Introducer Kit OEX
Vacuum Powered Body Fluid Collection Kit OJR
Laparoscope, General & Plastic Surgery GCJ
Manometer, Spinal-Fluid FMJ
Drape, Pure Latex Sheet, With Self-Retaining Finger Cot EYX
Infant Heel Warmer (Chemical Heat Pack) MPO
Angiography/Angioplasty Kit OEQ
Percutaneous Introducer Kit PXB
Neurological Test Kit PVP
Glossopharyngeal Anesthesia Kit OGF
Disposable Joint Aspiration/Injection Kit PPP
Syringe, Balloon Inflation, Exempt PTM
Lead Introducer Kit OFJ
Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit) FCM
Endoscope Introducer Kit NWU
Ear Irrigation Kit OGQ
Sterile Puncture Tray PYF
Urinary Drainage Collection Kit, For Indwelling Catheter FCN
Radiology-Diagnostic Kit OIP
Epidural Anesthesia Kit OGE
Probe And Director, Gastro-Urology FGM
Eye Tray OJK
Pacemaker, Cardiac, External Transcutaneous (Non-Invasive) DRO
Lumbar Puncture Tray (Adult & Pediatric) PWY
Nasogastric Feed Tube Kit PSB
Venous Ulcer Kit PYK
System, Measurement, Blood-Pressure, Non-Invasive DXN
Depressor, Tongue, Non-Surgical FMA
I.V. Start Kit LRS
Universal Drainage Tray PPD
Bedding, Disposable, Medical KME
Stocking, Elastic ILG
Specula, Ophthalmic HNC
Pump, Infusion FRN
Single Needle With Uni-Directional Pump Kit PPH
Support, Patient Position CCX
Tube, Levine FRQ
Suprapubic Cystostomy Catheter Kit NWP
Catheter Guide Wire Kit OFB
Thoracentesis Tray PXI
Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use LXG
Wound Dressing Kit MCY
Blade, Saw, General & Plastic Surgery, Surgical GFA
Urinometer, Mechanical EXR
Nasal Endotracheal Tube Holder Kit OGI
Pack, Hot Or Cold, Disposable IMD
Cutter, Surgical FZT
Cesarean Section Tray OHM
Pad, Eye HMP
Tourniquet, Pneumatic KCY
Disinfectant, Medical Devices LRJ
Arthrogram Tray OII
Mid-Stream Collection Kit PWZ
Device, Intravascular Catheter Securement KMK
Cardiovascular Surgical Instruments Tray OFA
Feeding Tube Kit PRR
Orthopedic Tray OJH
Accessories, Cleaning Brushes, For Endoscope MNL
Maternity Kit PVT
Tracheostomy Kit OGW
Applier, Surgical, Clip GDO
Device, Biofeedback HCC
Marker, Skin FZZ
Port Introducer Kit OKE
Tape And Bandage, Adhesive KGX
Urine Transport Kit (Excludes Hiv Testing) OHZ
Non-Surgical Gown OEA
Labor And Delivery Kit MLS
Body Fluids Barrier Kit OKH
Gauze / Sponge,Nonresorbable For External Use NAB
Surgical Cannulaes & Depth Gauge Kit For Arthroscopic Procedures PPR
Pudendal Anesthesia Kit PVW
Hook, Surgical, General & Plastic Surgery GDG
Trocar Kit OKX
Emergency Response Safety Kit OKI
Table And Attachments, Operating-Room BWN
Introducer, Catheter DYB
Connector, Catheter GCD
Single Needle (Co-Axial Flow) Dialysis Kit PPL
Vaginal Examination Tray PVX
Endoscopic Shunt Placement Kit PVL
Catheter, Peritoneal GBW
Tourniquet, Nonpneumatic GAX
Clamp HXD
Male External Catheterization Kit (Excludes Hiv Testing) PPC
Gingival Retraction Kit NYF
Cholecystectomy Kit PXS
Device, Percutaneous, Biopsy MJG
Pelvic Exam Kit MLT
Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment HWE
Dressing Change Tray OXQ
Suction Catheter Kit PYG
Percutaneous Atrial Catheter Kit OFK
Media, Coupling, Ultrasound MUI
Catheter, Intravascular, Diagnostic DQO
Laparoscopy Kit FDE
Stimulator, Nerve, Transcutaneous, For Pain Relief GZJ
Pelviscopy Kit PYD
Kit, Cord Blood Collection MYK
Ear, Nose, And Throat Surgical Tray OGR
Micro Pipette JRC
Dressing, Compression MHW
Prep Kit PXD
Endothelial Cell Harvesting Kit MFY
Accessory, Surgical Apparel LYU
Catheter, Continuous Irrigation GBQ
Light, Surgical, Accessories FTA
Dressing, Wound, Occlusive NAD
Insufflator, Laparoscopic HIF
Catheter, Straight EZD
Cable, Electrode IKD
Container, I.V. KPE
Light, Surgical, Ceiling Mounted FSY
Preservative, Cytological LEA
Bandage, Cast ITG
Solvent, Adhesive Tape KOX
Circumcision Tray OHG
Container, Specimen, Non-Sterile NNI
System, Blood Collection, Vacuum-Assisted, Manual KST
Oral Surgery Tray PWL
Apparatus, Suction, Operating-Room, Wall Vacuum Powered GCX
Forceps, Biopsy, Gynecological HFB
Laser Blood Flow Kit OFI
Forensic Evidence Sexual Assault Kit OHE
Blood Administration Kit PWO
Sex Crimes / Sexual Assault / Suspect Evidence Collection Kit (Excludes Hiv Testing) OID
Emergency Obstetrical Kit OKU
Pad, Menstrual, Unscented HHD
Forceps HTD
Blood Specimen Collection Convenience Kit (Excludes Hiv) PQD
Stand, Infusion FOX
Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use JQC
Electrosurgical Electrode Kit NWI
Tissue Processing Kit PFU
Catheter, Coude EZC
Anesthesia Kit OFQ
Peritoneal Dialysis Administration Kit PPJ
Lumbar Drainage Catheter Kit PVO
Cricothyrotomy Kit OGP
Accessories, Catheter, G-U KNY
Central Venous Catheter Dressing Change Kit PEZ
Catheter Care Tray OHR
Cardiovascular Procedure Kit OEZ
Peripheral Catheter Insertion Kit OWL
Electrode, Circular (Spiral), Scalp And Applicator HGP
Lubricant, Patient KMJ
Plaque Disclosing Kit NYH
Laparoscopic Jejunostomy Kit PSA
Dental Prophylaxis Kit NYC
Prostate Seeding Kit OIN
Lapping Tool Kit NYG
Truss, Umbilical EXM
Brachial Plexus Anesthesia Kit OGA
Drape, Patient, Ophthalmic HMT
Chemotherapy Spill Clean-Up Kit PWT
Dental Implant Surgical Tray OFY
Ring (Wound Protector), Drape Retention, Internal KGW
Camera, Surgical And Accessories KQM
Urinary Irrigation Kit PPF
Clamp, Surgical, General & Plastic Surgery GDJ
Bottle, Collection, Vacuum KDQ
Surgical Eye Tray PZG
Gastrostomy Jejunostomy Feeding Tube Kit PRY
Spinal Anesthesia Kit OFU
Gown, Isolation, Surgical FYC
Container, Specimen, Sterile FMH
Cytology Kit OKY
Applicator, Absorbent Tipped, Non-Sterile KXF
Dressing, Wound, Hydrogel Without Drug And/Or Biologic NAE
Angioscopic Valvulotome Kit OER
Recorder, Paper Chart DSF
Circuit, Breathing (W Connector, Adaptor, Y Piece) CAI
Obstetrical Kit OKV
Thoracic Catheter Insertion Tray PYI
Tracheobronchial Suction Catheter Kit OFR
Bandage, Elastic FQM
Endodontic Kit NYD
Fiber, Medical, Absorbent FRL
Cardioplegia Solution Administration Kit OET
Tape, Measuring, Rulers And Calipers FTY
Clip, Implantable FZP
Tracheal Suction Set OFS
Tourniquet Kit OJS
Instrument, Surgical, Disposable KDC
Multi-Lumen Hemodialysis Catheterization Kit PPO
Tubing, Noninvasive GAZ
Blood Alcohol Kit (Excludes Hiv Testing) OIC
Basic Set-Up Tray PXN
Bladder Irrigation Kit PPA
Kit, Surgical Instrument, Disposable KDD
Electrode, Electrocardiograph DRX
Burn Kit Without Drug OJJ
Drape, Urological, Disposable EYY
Rectal Dilator Kit PSJ
Phlebotomy Blood Collection Kit OFM
Catheter (Gastric, Colonic, Etc.), Irrigation And Aspiration KDH
Drape, Surgical, Antimicrobial KKX
Laparascopic Sphincterotomy Kit PXZ
Electrode, Electrocardiograph, Multi-Function MLN
Laparoscopic Gastrostomy Kit PSD
Aspiration Tray OJT
Single Use Instrument Tray OJV
Blood And Urine Collection Kit (Excludes Hiv Testing) OIB
Curette, Uterine HCY
Kit, Test, Pregnancy, Hcg, Over The Counter LCX
Apparatus, Suction, Single Patient Use, Portable, Nonpowered GCY
Scale, Stand-On, Patient FRI
Instrument, Manual, Surgical, General Use MDM
LDQ
Biopsy Needle Guide Kit OIJ
Gastro-Urology Biopsy Kit PRV
Board, Arm (With Cover), Sterile BTX
Nephroscope Set PPE
Tray, Start/Stop (Including Contents), Dialysis FKG
Cover, Barrier, Protective MMP
Wound Drainage Kit PYL
Suture Kit OVN
Perineal Irrigation Kit PSI
Laryngoscope Kit OGH
Stocking, Medical Support (To Prevent Pooling Of Blood In Legs) DWL
Cotton, Roll EFN
Needle, Aspiration And Injection, Disposable GAA
Thermometer, Clinical Mercury FLK
Instrument, Surgical, Non-Powered HAO
Band, Elastic, Orthodontic ECI
Chest Drainage Kit PAD
General Purpose Dental Tray OFX
Retractor GAD
Surgical Instruments, G-U, Manual (And Accessories) KOA
Test, Luteinizing Hormone (Lh), Over The Counter NGE
Urine Collection Kit (Excludes Hiv Testing) OIE
Regional Anesthesia Kit OFV
Drape, Surgical, Exempt PUI
Evacuator, Oral Cavity EHZ
Scissors, Medical, Disposable JOK
Trocar DRC
Obstetrical Anesthesia Kit PVU
Forceps, General & Plastic Surgery GEN
Gown, Non-Sterile, Non-Isolation, Intended To Provide Moderate Or High Barrier Protection QPC
Tube, Tissue Culture KJG
System, Urine Drainage, Closed, For Nonindwelling Catheter, Sterile EYZ
Gastrostomy Tube Kit PRZ
Vomitus Clean-Up Kit PXM
Catheter Introducer Kit OFC
Discography Kit OIL
Surgical Retractor Kit PYH
Dressing, Wound, Hydrophilic NAC
Guide, Needle, Surgical GDF
Fluid Drainage Tray PXU
Radiographic Contrast Tray OIO
Cannula, Ophthalmic HMX
Irrigation Kit (Wounds) PXY

Proprietary Names

CARDINAL HEALTH NITRILE EXAMINATION GLOVES EXTENDED CUFF Stainless Steel Tongue Cleaner

Establishment Types

Complaint File Establishment per 21 CFR 820.198