Cardinal Health

FDA Device Registration & Listing · Hazelwood, MO, US · Registration 1921846

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
1921846
FEI Number
1921846
Entity Name
Cardinal Health
City/State/Country
Hazelwood, MO, US
Establishment Address
444 JAMES SOUTH MCDONNELL BLVD., Hazelwood, MO 63042, US
Establishment Type(s)
Develop Specifications But Do Not Manufacture At This Facility
Owner / Operator
Cardinal Health 200, LLC (Owner Number: 9028292)
Owner / Operator Contact Address
3651 Birchwood Drive, --, Waukegan, IL 60085, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
PMA Number
N/A

All Registered Proprietary Names

CARDINAL HEALTH NITRILE EXAMINATION GLOVES EXTENDED CUFF Stainless Steel Tongue Cleaner

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
GIM Tubes, Vacuum Sample, With Anticoagulant Clinical Chemistry Class 2 862.1675 2010-07-02
MMK Container, Sharps General Hospital Class 2 880.5570 2007-11-30
FLL Continuous Measurement Thermometer General Hospital Class 2 880.2910 2018-07-27
GIM Tubes, Vacuum Sample, With Anticoagulant Clinical Chemistry Class 2 862.1675 2008-01-11
FMF Syringe, Piston General Hospital Class 2 880.5860 2010-11-11
FRO Dressing, Wound, Drug Unknown Class U N/A 2013-05-03
FOD Device, Occlusion, Umbilical General Hospital Class 1 880.5950 2024-06-10
FRL Fiber, Medical, Absorbent General Hospital Class 1 880.5300 1999-08-04
FOK Pad, Neonatal Eye General Hospital Class 1 880.5270 2006-05-26
PIF Gastrointestinal Tubes With Enteral Specific Connectors Gastroenterology, Urology Class 2 876.5980 2022-05-25
FEG Tube, Double Lumen For Intestinal Decompression And/Or Intubation Gastroenterology, Urology Class 2 876.5980 2022-05-25
ILG Stocking, Elastic Physical Medicine Class 1 890.3475 2003-07-01
GAA Needle, Aspiration And Injection, Disposable General, Plastic Surgery Class 1 878.4800 2005-04-13
KGO Surgeon'S Gloves General, Plastic Surgery Class 1 878.4460 2020-01-31
LXG Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use Clinical Chemistry Class 1 862.2050 2009-05-15
FXX Mask, Surgical General, Plastic Surgery Class 2 878.4040 2006-04-11
FCE Enema Kit Gastroenterology, Urology Class 1 876.5210 2002-02-23
OMP Negative Pressure Wound Therapy Powered Suction Pump General, Plastic Surgery Class 2 878.4780 2021-09-21
GDJ Clamp, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 2007-04-26
KNT Tubes, Gastrointestinal (And Accessories) Gastroenterology, Urology Class 2 876.5980 2018-07-27
DYB Introducer, Catheter Cardiovascular Class 2 870.1340 2019-06-17
KNT Tubes, Gastrointestinal (And Accessories) Gastroenterology, Urology Class 2 876.5980 2008-01-10
FMI Needle, Hypodermic, Single Lumen General Hospital Class 2 880.5570 2007-12-03
KYZ Syringe, Irrigating (Non Dental) General Hospital Class 1 880.6960 2003-08-05
MGQ Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic Unknown Class U N/A 2008-01-10
NAB Gauze / Sponge,Nonresorbable For External Use General, Plastic Surgery Class 1 878.4014 2001-08-22
KOD Catheter, Urological Gastroenterology, Urology Class 2 876.5130 2018-07-27
FZX Guide, Surgical, Instrument General, Plastic Surgery Class 1 878.4800 2011-07-08
MMK Container, Sharps General Hospital Class 2 880.5570 2007-11-30
PTM Syringe, Balloon Inflation, Exempt Cardiovascular Class 2 870.1650 2020-08-27
JKA Tubes, Vials, Systems, Serum Separators, Blood Collection Clinical Chemistry Class 2 862.1675 2008-01-11
HED Douche Apparatus, Vaginal, Therapeutic Obstetrics/Gynecology Class 1 884.5900 2002-02-23
KYR Bag, Ice General Hospital Class 1 880.6050 2006-04-11
FXX Mask, Surgical General, Plastic Surgery Class 2 878.4040 2019-12-05
OEA Non-Surgical Gown General, Plastic Surgery Class 1 878.4040 2009-09-23
KNT Tubes, Gastrointestinal (And Accessories) Gastroenterology, Urology Class 2 876.5980 2017-08-14
EZL Catheter, Retention Type, Balloon Gastroenterology, Urology Class 2 876.5130 2007-12-17
JOW Sleeve, Limb, Compressible Cardiovascular Class 2 870.5800 2018-07-27
KOD Catheter, Urological Gastroenterology, Urology Class 2 876.5130 2018-05-22
FYA Gown, Surgical General, Plastic Surgery Class 2 878.4040 2008-04-15
DYN Mouthpiece, Saliva Ejector Dental Class 1 872.6640 2004-06-03
LZH Pump, Infusion, Enteral General Hospital Class 2 880.5725 2018-07-27
KMF Bandage, Liquid General Hospital Class 1 880.5090 2008-01-10
KYX Dispenser, Liquid Medication General Hospital Class 1 880.6430 1999-10-14
KGO Surgeon'S Gloves General, Plastic Surgery Class 1 878.4460 2016-05-23
LZC Medical Glove, Specialty General Hospital Class 1 880.6250 2016-05-23
NAE Dressing, Wound, Hydrogel Without Drug And/Or Biologic General, Plastic Surgery Class 1 878.4022 2008-01-10
PPB Foley Catheter Kit (Excludes Hiv Testing) Gastroenterology, Urology Class 2 876.5130 2018-04-20
FSD Binder, Abdominal General Hospital Class 1 880.5160 1996-12-16
EXR Urinometer, Mechanical Gastroenterology, Urology Class 2 876.1800 1993-01-14
GIM Tubes, Vacuum Sample, With Anticoagulant Clinical Chemistry Class 2 862.1675 2023-02-01
KGO Surgeon'S Gloves General, Plastic Surgery Class 1 878.4460 1977-12-31
FMH Container, Specimen, Sterile Pathology Class 1 864.3250 2006-02-13
KNT Tubes, Gastrointestinal (And Accessories) Gastroenterology, Urology Class 2 876.5980 2019-12-11
KXO Monitor, Pressure, Intrauterine Obstetrics/Gynecology Class 2 884.2700 2006-09-22
SDV Clinical Electronic Thermometer General Hospital Class 2 880.2910 2026-02-20
CCX Support, Patient Position Anesthesiology Class 1 868.6820 2010-05-03
HMT Drape, Patient, Ophthalmic General, Plastic Surgery Class 2 878.4370 2016-04-14
GBM Catheter, Urethral Gastroenterology, Urology Class 2 876.5130 2007-12-17
KOD Catheter, Urological Gastroenterology, Urology Class 2 876.5130 2018-07-27
FOS Catheter, Umbilical Artery General Hospital Class 2 880.5200 2008-01-17
KNT Tubes, Gastrointestinal (And Accessories) Gastroenterology, Urology Class 2 876.5980 2017-08-14
LRO General Surgery Tray General, Plastic Surgery Class 2 878.4370 2021-08-16
HGP Electrode, Circular (Spiral), Scalp And Applicator Obstetrics/Gynecology Class 2 884.2675 2008-01-11
LZH Pump, Infusion, Enteral General Hospital Class 2 880.5725 2023-01-24
KNT Tubes, Gastrointestinal (And Accessories) Gastroenterology, Urology Class 2 876.5980 2019-06-17
KGO Surgeon'S Gloves General, Plastic Surgery Class 1 878.4460 2011-10-06
FXX Mask, Surgical General, Plastic Surgery Class 2 878.4040 2008-04-16
PIF Gastrointestinal Tubes With Enteral Specific Connectors Gastroenterology, Urology Class 2 876.5980 2019-12-11
FEG Tube, Double Lumen For Intestinal Decompression And/Or Intubation Gastroenterology, Urology Class 2 876.5980 2019-12-11
FRO Dressing, Wound, Drug Unknown Class U N/A 2008-01-10
GIM Tubes, Vacuum Sample, With Anticoagulant Clinical Chemistry Class 2 862.1675 2008-01-11
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2011-04-19
FRQ Tube, Levine Gastroenterology, Urology Class 2 876.5980 2014-03-24
MMK Container, Sharps General Hospital Class 2 880.5570 2007-11-30
KNT Tubes, Gastrointestinal (And Accessories) Gastroenterology, Urology Class 2 876.5980 2008-01-10
KGO Surgeon'S Gloves General, Plastic Surgery Class 1 878.4460 2011-06-17
LZC Medical Glove, Specialty General Hospital Class 1 880.6250 2011-06-17
LZH Pump, Infusion, Enteral General Hospital Class 2 880.5725 2018-07-27
FYA Gown, Surgical General, Plastic Surgery Class 2 878.4040 2006-04-11
EYZ System, Urine Drainage, Closed, For Nonindwelling Catheter, Sterile Gastroenterology, Urology Class 1 876.5250 2011-07-11
HCC Device, Biofeedback Neurology Class 2 882.5050 2024-06-21
KGO Surgeon'S Gloves General, Plastic Surgery Class 1 878.4460 2012-05-07
FFG Device, Urine Flow Rate Measuring, Non-Electrical, Disposable Gastroenterology, Urology Class 2 876.1800 2002-02-23
LZH Pump, Infusion, Enteral General Hospital Class 2 880.5725 2023-01-18
KNX Collector, Urine, (And Accessories) For Indwelling Catheter Gastroenterology, Urology Class 2 876.5250 2011-11-10
KOD Catheter, Urological Gastroenterology, Urology Class 2 876.5130 2023-12-28
KOX Solvent, Adhesive Tape General, Plastic Surgery Class 1 878.4730 2004-04-07
EZD Catheter, Straight Gastroenterology, Urology Class 2 876.5130 2008-01-18
NAC Dressing, Wound, Hydrophilic General, Plastic Surgery Class 1 878.4018 2013-03-26
KPE Container, I.V. General Hospital Class 2 880.5025 2008-01-11
KGO Surgeon'S Gloves General, Plastic Surgery Class 1 878.4460 2010-10-25
KNT Tubes, Gastrointestinal (And Accessories) Gastroenterology, Urology Class 2 876.5980 2008-01-10
KGO Surgeon'S Gloves General, Plastic Surgery Class 1 878.4460 1977-12-31
GAB Needle, Suturing, Disposable General, Plastic Surgery Class 1 878.4800 2009-07-08
LWK Razor, Surgical General, Plastic Surgery Class 1 878.4800 1999-02-12
QPC Gown, Non-Sterile, Non-Isolation, Intended To Provide Moderate Or High Barrier Protection General, Plastic Surgery Class 2 878.4040 2019-04-29
FXX Mask, Surgical General, Plastic Surgery Class 2 878.4040 2015-04-29
HFX Clamp, Circumcision Obstetrics/Gynecology Class 2 884.4530 2009-07-02
HCC Device, Biofeedback Neurology Class 2 882.5050 2023-11-29
KNT Tubes, Gastrointestinal (And Accessories) Gastroenterology, Urology Class 2 876.5980 2008-01-18
FOX Stand, Infusion General Hospital Class 1 880.6990 1995-08-03
FYF Cap, Surgical General, Plastic Surgery Class 1 878.4040 1990-01-03
FYA Gown, Surgical General, Plastic Surgery Class 2 878.4040 2006-04-11
JOW Sleeve, Limb, Compressible Cardiovascular Class 2 870.5800 2023-08-17
FMI Needle, Hypodermic, Single Lumen General Hospital Class 2 880.5570 2007-12-05
ERY Drape, Surgical, Ent General, Plastic Surgery Class 2 878.4370 2017-08-07
FZZ Marker, Skin General, Plastic Surgery Class 1 878.4660 2009-06-15
KGO Surgeon'S Gloves General, Plastic Surgery Class 1 878.4460 2011-10-06
FRN Pump, Infusion General Hospital Class 2 880.5725 2018-07-27
JOW Sleeve, Limb, Compressible Cardiovascular Class 2 870.5800 2007-12-18
DZM Needle, Dental Dental Class 1 872.4730 1977-12-23
KDQ Bottle, Collection, Vacuum General Hospital Class 2 880.6740 1995-08-01
KCY Tourniquet, Pneumatic General, Plastic Surgery Class 1 878.5910 2021-08-16
KDT Container, Specimen Mailer And Storage, Sterile Pathology Class 1 864.3250 2002-05-07
KNT Tubes, Gastrointestinal (And Accessories) Gastroenterology, Urology Class 2 876.5980 2008-01-18
FOS Catheter, Umbilical Artery General Hospital Class 2 880.5200 2008-01-16
EYX Drape, Pure Latex Sheet, With Self-Retaining Finger Cot General, Plastic Surgery Class 2 878.4370 2017-08-11
QDO Fentanyl And Other Opioid Protection Glove General Hospital Class 1 880.6250 2026-02-10
LZC Medical Glove, Specialty General Hospital Class 1 880.6250 2026-02-10
OPJ Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs General Hospital Class 1 880.6250 2026-02-10
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2026-02-10
MMK Container, Sharps General Hospital Class 2 880.5570 2007-11-30
KNT Tubes, Gastrointestinal (And Accessories) Gastroenterology, Urology Class 2 876.5980 2014-04-11
BSY Catheters, Suction, Tracheobronchial Anesthesiology Class 1 868.6810 1999-03-30
PRM Enteral Administration Kit (Adult & Pediatric) Gastroenterology, Urology Class 2 876.5980 2018-08-09
CBH Device, Fixation, Tracheal Tube Anesthesiology Class 1 868.5770 2025-08-12
GEC Brush, Scrub, Operating-Room General, Plastic Surgery Class 1 878.4800 1995-08-02
PNR Enteral Syringes With Enteral Specific Connectors Gastroenterology, Urology Class 2 876.5980 2016-07-25
MKJ Automated External Defibrillators (Non-Wearable) Cardiovascular Class 3 870.5310 2009-09-03
OMP Negative Pressure Wound Therapy Powered Suction Pump General, Plastic Surgery Class 2 878.4780 2020-08-06
LYU Accessory, Surgical Apparel General, Plastic Surgery Class 1 878.4040 1994-05-23
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2006-04-11
GAZ Tubing, Noninvasive General Hospital Class 2 880.6740 2007-04-26
MKJ Automated External Defibrillators (Non-Wearable) Cardiovascular Class 3 870.5310 2020-10-07
DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass Cardiovascular Class 2 870.4210 2008-01-17
JOW Sleeve, Limb, Compressible Cardiovascular Class 2 870.5800 2024-10-23
EYQ Garment, Protective, For Incontinence Gastroenterology, Urology Class 1 876.5920 2013-06-03
FNY Basin, Emesis General Hospital Class 1 880.6730 2002-05-07
EYY Drape, Urological, Disposable General, Plastic Surgery Class 2 878.4370 2017-08-11
LKB Pad, Alcohol, Device Disinfectant Unknown Class U N/A 2008-01-10
EFQ Gauze/Sponge, Internal Unknown Class U N/A 2008-01-10
KNT Tubes, Gastrointestinal (And Accessories) Gastroenterology, Urology Class 2 876.5980 2016-10-28
FOS Catheter, Umbilical Artery General Hospital Class 2 880.5200 2008-01-17
KMF Bandage, Liquid General Hospital Class 1 880.5090 2008-01-10
KNT Tubes, Gastrointestinal (And Accessories) Gastroenterology, Urology Class 2 876.5980 2018-07-27
KOD Catheter, Urological Gastroenterology, Urology Class 2 876.5130 2018-07-27
JOW Sleeve, Limb, Compressible Cardiovascular Class 2 870.5800 2017-04-04
KDH Catheter (Gastric, Colonic, Etc.), Irrigation And Aspiration Gastroenterology, Urology Class 2 876.5980 2018-07-27
GCD Connector, Catheter General, Plastic Surgery Class 1 878.4200 2013-07-17
MLN Electrode, Electrocardiograph, Multi-Function Cardiovascular Class 2 870.2360 2008-01-11
MKJ Automated External Defibrillators (Non-Wearable) Cardiovascular Class 3 870.5310 2008-01-11
GXY Electrode, Cutaneous Neurology Class 2 882.1320 2008-01-10
FMF Syringe, Piston General Hospital Class 2 880.5860 2008-01-11
FMF Syringe, Piston General Hospital Class 2 880.5860 2008-01-11
GBM Catheter, Urethral Gastroenterology, Urology Class 2 876.5130 2008-01-18
BYX Tubing, Pressure And Accessories Anesthesiology Class 1 868.5860 2001-06-15
JOW Sleeve, Limb, Compressible Cardiovascular Class 2 870.5800 2018-07-27
BTX Board, Arm (With Cover), Sterile General, Plastic Surgery Class 1 878.3910 2004-03-22
FSM Tray, Surgical, Instrument General, Plastic Surgery Class 1 878.4800 2006-05-12
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2008-06-20
GDY Gauze/Sponge, Internal, X-Ray Detectable General, Plastic Surgery Class 1 878.4450 2005-07-11
KGO Surgeon'S Gloves General, Plastic Surgery Class 1 878.4460 2022-03-22
LZC Medical Glove, Specialty General Hospital Class 1 880.6250 2022-03-22
KMF Bandage, Liquid General Hospital Class 1 880.5090 2008-01-10
EZL Catheter, Retention Type, Balloon Gastroenterology, Urology Class 2 876.5130 2013-09-03
KMJ Lubricant, Patient General Hospital Class 1 880.6375 2013-12-03
FYA Gown, Surgical General, Plastic Surgery Class 2 878.4040 2023-08-07
HMW Drape, Microscope, Ophthalmic General, Plastic Surgery Class 2 878.4370 2017-08-11
FQM Bandage, Elastic General Hospital Class 1 880.5075 2007-04-26
FLL Continuous Measurement Thermometer General Hospital Class 2 880.2910 2008-01-11
JOW Sleeve, Limb, Compressible Cardiovascular Class 2 870.5800 2007-12-18
JOW Sleeve, Limb, Compressible Cardiovascular Class 2 870.5800 2017-01-05
KNT Tubes, Gastrointestinal (And Accessories) Gastroenterology, Urology Class 2 876.5980 2019-12-11
DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass Cardiovascular Class 2 870.4210 2008-01-16
MLS Labor And Delivery Kit Obstetrics/Gynecology Class 2 884.4530 2008-06-17
BYZ Trap, Sterile Specimen General Hospital Class 2 880.6740 2021-06-25
KNW Instrument, Biopsy Gastroenterology, Urology Class 2 876.1075 2019-06-17
FMI Needle, Hypodermic, Single Lumen General Hospital Class 2 880.5570 2007-12-03
EIC Syringe, Periodontic, Endodontic, Irrigating Dental Class 1 872.4565 1977-12-23
KGO Surgeon'S Gloves General, Plastic Surgery Class 1 878.4460 2011-05-11
LRJ Disinfectant, Medical Devices General Hospital Class 1 880.6890 2005-07-11
FPK Tubing, Fluid Delivery General Hospital Class 2 880.5440 2008-01-28
KGO Surgeon'S Gloves General, Plastic Surgery Class 1 878.4460 1977-12-31
LZC Medical Glove, Specialty General Hospital Class 1 880.6250 2008-04-24
ITG Bandage, Cast Physical Medicine Class 1 890.3025 1999-08-04
GBX Catheter, Irrigation General, Plastic Surgery Class 1 878.4200 1998-08-17
KGZ Accessories, Catheter General, Plastic Surgery Class 1 878.4200 2021-08-17
JOL Catheter And Tip, Suction General Hospital Class 2 880.6740 2007-04-26
BYY Tube, Aspirating, Flexible, Connecting General Hospital Class 2 880.6740 1995-08-02
KOD Catheter, Urological Gastroenterology, Urology Class 2 876.5130 2008-01-18
FMI Needle, Hypodermic, Single Lumen General Hospital Class 2 880.5570 2008-01-16
GEA Cannula, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 2005-04-06
FYC Gown, Isolation, Surgical General, Plastic Surgery Class 2 878.4040 2016-07-29
OPJ Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs General Hospital Class 1 880.6250 2024-08-26
LZC Medical Glove, Specialty General Hospital Class 1 880.6250 2024-08-26
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2024-08-26
OMP Negative Pressure Wound Therapy Powered Suction Pump General, Plastic Surgery Class 2 878.4780 2017-03-07
FMI Needle, Hypodermic, Single Lumen General Hospital Class 2 880.5570 2008-01-28
PWY Lumbar Puncture Tray (Adult & Pediatric) General Hospital Class 2 880.5570 2018-06-06
GZJ Stimulator, Nerve, Transcutaneous, For Pain Relief Neurology Class 2 882.5890 2008-01-10
KNT Tubes, Gastrointestinal (And Accessories) Gastroenterology, Urology Class 2 876.5980 2008-01-18
KOD Catheter, Urological Gastroenterology, Urology Class 2 876.5130 2007-12-17
KDC Instrument, Surgical, Disposable General, Plastic Surgery Class 1 878.4800 1994-02-02
BTO Tube, Tracheostomy (W/Wo Connector) Anesthesiology Class 2 868.5800 2008-01-18
GXY Electrode, Cutaneous Neurology Class 2 882.1320 2008-01-10
GXY Electrode, Cutaneous Neurology Class 2 882.1320 2010-02-03
JOW Sleeve, Limb, Compressible Cardiovascular Class 2 870.5800 2010-10-18
KGO Surgeon'S Gloves General, Plastic Surgery Class 1 878.4460 2008-04-24
NAD Dressing, Wound, Occlusive General, Plastic Surgery Class 1 878.4020 2006-03-20
NAD Dressing, Wound, Occlusive General, Plastic Surgery Class 1 878.4020 2010-08-25
GXY Electrode, Cutaneous Neurology Class 2 882.1320 2008-01-10
KMF Bandage, Liquid General Hospital Class 1 880.5090 2008-01-10
FXX Mask, Surgical General, Plastic Surgery Class 2 878.4040 2008-04-15
OWL Peripheral Catheter Insertion Kit General Hospital Class 2 880.5200 2011-11-11
PIF Gastrointestinal Tubes With Enteral Specific Connectors Gastroenterology, Urology Class 2 876.5980 2015-08-06
FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days General Hospital Class 2 880.5200 2014-05-05
LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days General Hospital Class 2 880.5970 2014-05-05
MMK Container, Sharps General Hospital Class 2 880.5570 2007-12-03
FYA Gown, Surgical General, Plastic Surgery Class 2 878.4040 2017-06-19
DRX Electrode, Electrocardiograph Cardiovascular Class 2 870.2360 2014-12-04
GIM Tubes, Vacuum Sample, With Anticoagulant Clinical Chemistry Class 2 862.1675 2008-01-11
IKD Cable, Electrode Physical Medicine Class 2 890.1175 2001-08-31
GCY Apparatus, Suction, Single Patient Use, Portable, Nonpowered General, Plastic Surgery Class 1 878.4680 2000-08-03
KGX Tape And Bandage, Adhesive General Hospital Class 1 880.5240 2001-07-27
FMI Needle, Hypodermic, Single Lumen General Hospital Class 2 880.5570 2007-12-05
OMP Negative Pressure Wound Therapy Powered Suction Pump General, Plastic Surgery Class 2 878.4780 2017-12-05
GXY Electrode, Cutaneous Neurology Class 2 882.1320 2008-01-10
FRG Wrap, Sterilization General Hospital Class 2 880.6850 2018-12-19
KNT Tubes, Gastrointestinal (And Accessories) Gastroenterology, Urology Class 2 876.5980 2008-01-18
FHQ Holder, Needle, Gastroenterologic Gastroenterology, Urology Class 1 876.4730 2007-04-20
FMI Needle, Hypodermic, Single Lumen General Hospital Class 2 880.5570 2009-10-27
FMA Depressor, Tongue, Non-Surgical General Hospital Class 1 880.6230 2026-06-12
OMP Negative Pressure Wound Therapy Powered Suction Pump General, Plastic Surgery Class 2 878.4780 2015-05-14
LRO General Surgery Tray General, Plastic Surgery Class 2 878.4370 2009-05-06
FEG Tube, Double Lumen For Intestinal Decompression And/Or Intubation Gastroenterology, Urology Class 2 876.5980 2008-01-18
EZL Catheter, Retention Type, Balloon Gastroenterology, Urology Class 2 876.5130 2021-03-01
OJS Tourniquet Kit General, Plastic Surgery Class 1 878.5900 2011-11-11
KNT Tubes, Gastrointestinal (And Accessories) Gastroenterology, Urology Class 2 876.5980 2008-01-10
FMI Needle, Hypodermic, Single Lumen General Hospital Class 2 880.5570 2024-02-07
FMF Syringe, Piston General Hospital Class 2 880.5860 2024-02-07
MEG Syringe, Antistick General Hospital Class 2 880.5860 2024-02-07
KNY Accessories, Catheter, G-U Gastroenterology, Urology Class 2 876.5130 2008-01-18
FLL Continuous Measurement Thermometer General Hospital Class 2 880.2910 2018-07-27
KNT Tubes, Gastrointestinal (And Accessories) Gastroenterology, Urology Class 2 876.5980 2018-07-27
MMK Container, Sharps General Hospital Class 2 880.5570 2007-11-30
FMF Syringe, Piston General Hospital Class 2 880.5860 2007-12-05
HMP Pad, Eye General, Plastic Surgery Class 1 878.4440 2001-07-26
KGO Surgeon'S Gloves General, Plastic Surgery Class 1 878.4460 2009-11-02
FOS Catheter, Umbilical Artery General Hospital Class 2 880.5200 2016-06-08
DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass Cardiovascular Class 2 870.4210 2008-01-16
KGO Surgeon'S Gloves General, Plastic Surgery Class 1 878.4460 2016-07-11
DWS Instruments, Surgical, Cardiovascular Cardiovascular Class 1 870.4500 2007-04-20
JOW Sleeve, Limb, Compressible Cardiovascular Class 2 870.5800 2007-12-18
KGZ Accessories, Catheter General, Plastic Surgery Class 1 878.4200 1999-08-04
FYA Gown, Surgical General, Plastic Surgery Class 2 878.4040 2015-06-02
PNR Enteral Syringes With Enteral Specific Connectors Gastroenterology, Urology Class 2 876.5980 2025-01-06
FYA Gown, Surgical General, Plastic Surgery Class 2 878.4040 2022-07-20
PIF Gastrointestinal Tubes With Enteral Specific Connectors Gastroenterology, Urology Class 2 876.5980 2018-12-11
KNT Tubes, Gastrointestinal (And Accessories) Gastroenterology, Urology Class 2 876.5980 2018-12-11
DWL Stocking, Medical Support (To Prevent Pooling Of Blood In Legs) General Hospital Class 2 880.5780 2014-09-16
FSY Light, Surgical, Ceiling Mounted General, Plastic Surgery Class 2 878.4580 2016-08-22
FMF Syringe, Piston General Hospital Class 2 880.5860 2008-01-10
GXY Electrode, Cutaneous Neurology Class 2 882.1320 2008-01-10
EZL Catheter, Retention Type, Balloon Gastroenterology, Urology Class 2 876.5130 2008-01-18

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Cardinal Health 200, LLC
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3004839227 Cardinal Health Malta 212 Ltd Marsa, MT
3015541720 Cardinal Health Germany Manufacturing GmbH Halberstadt Saxony-Anhalt, DE
1033903 Cardinal Health Greenwood, SC, US
9611018 Cardinal Health Ireland Manufacturing Limited TULLAMORE Offaly, IE
8040459 Kendall-Gammatron Limited SAMPRAN Nakhon Pathom, TH

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K010462 Avita Corporation AVITA PICCOLO/EXATO INFARED EAR THERMOMETER (TS2 & TS4 SERIES) 2001-04-11
K760421 Arbrook Mfg. Corp. THERMOMETER, SURVALENT-ELECTRONIC 1976-08-23
K813409 Yellow Springs Instrument Co., Inc. MODEL 2100 DUAL-DISPLAY TELE-THERMOMETER 1981-12-18
K830039 Science Development Corp. SDC RECTAL TEMP. PROBE PRODUCT #1020 1983-02-23
K842199 Sharp Electronics Corp. ELEC. DIGITAL THERMOMETER MT-20 & 30 1984-07-18

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0003-04 Liberty Medical Supplies 2
Liberty brand Insulin Syringes for use with U-100 insulin, 1/2 cc X 30G X 5/16'' syringes
Z-0004-04 Liberty Medical Supplies 2
Liberty brand Insulin Syringes for use with U-100 insulin, 1 cc X 29G X 1/2 '' insulin syringes
Z-0005-04 Liberty Medical Supplies 2
Liberty brand Insulin Syringes for use with U-100 insulin, 1/2 cc X 29G X 1/2 '' insulin syringes
Z-0005-2024 Fresenius Medical Care Holdings, Inc. 2
10ML SYRINGE LUER LOCK W/OUT NEEDLE, Part Number 15-R010-0, 100 per box, 12 boxes to a case
Z-0006-2024 Fresenius Medical Care Holdings, Inc. 2
10ML SYRINGE LUER LOCK W/NEEDLE, Part Number 15-10ML-0, 100 per box, 12 boxes per case

Similar Registrations

Registration Number Establishment Name Location
1917413 BECTON, DICKINSON & CO. BROKEN BOW, NE, US
1061124 Sterigenics U.S., LLC Charlotte, NC, US
2029015 Sterigenics U.S., LLC Ontario, CA, US
9617032 Becton, Dickinson & Company (BD) Plymouth Devon, GB
3013557562 CBR ENTERPRISE LIMITED Hong Kong, HK
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1921846. Last updated year: 2026. Please use registration number 1921846 when referencing this establishment in official correspondence.
Legal Disclaimer: AvaSpecs is not affiliated with the FDA or any government agency and does not provide medical, legal, regulatory, safety, approval, clearance, effectiveness, endorsement, or compliance advice. This index page is built using public record archives and does not represent an official regulatory determination.
Account Required Full available specs will require a free AvaSpecs account.