Cardinal Health 200, LLC

FDA Device Registration & Listing · El Paso, TX, US · Registration 3007329020

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
3007329020
FEI Number
3007329020
Entity Name
Cardinal Health 200, LLC
City/State/Country
El Paso, TX, US
Establishment Address
1320 Don Haskins, Suite A, El Paso, TX 79936, US
Establishment Type(s)
Manufacture Medical Device
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
N/A
PMA Number
N/A

All Registered Proprietary Names

No proprietary names listed under this establishment.

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
PVY Vasovasostomy Set Gastroenterology, Urology Class 1 876.4730 2018-06-06
HIO Sampler, Amniotic Fluid (Amniocentesis Tray) Obstetrics/Gynecology Class 1 884.1550 2006-05-18
OHD Gynecological Laparoscopic Kit Obstetrics/Gynecology Class 2 884.1720 2011-10-12
OHH Breast Pump Kit Obstetrics/Gynecology Class 2 884.5160 2011-11-14
OFE Central Venous Blood Pressure Kit Cardiovascular Class 2 870.1140 2011-06-27
OIJ Biopsy Needle Guide Kit Radiology Class 2 892.1560 2011-11-10
PRU Gastric Lavage Kit (Adult Or Pediatric Use) Gastroenterology, Urology Class 2 876.4370 2018-06-05
OWL Peripheral Catheter Insertion Kit General Hospital Class 2 880.5200 2011-11-11
PXS Cholecystectomy Kit General, Plastic Surgery Class 1 878.4800 2018-07-02
MFY Endothelial Cell Harvesting Kit Cardiovascular Class 2 870.4075 2011-11-09
LRW Scissors, General, Surgical General, Plastic Surgery Class 1 878.4800 2007-04-20
PRR Feeding Tube Kit Gastroenterology, Urology Class 2 876.5980 2018-06-05
OKW Seminal Fluid Collection Kit Obstetrics/Gynecology Class 2 884.5300 2011-11-14
OGB Caudal Anesthesia Kit Anesthesiology Class 2 868.5140 2011-11-09
PIN Kidney Perfusion Kit Gastroenterology, Urology Class 2 876.5880 2018-03-15
PXW Herniorraphy Kit General, Plastic Surgery Class 1 878.4800 2018-07-02
OFH Digital Angiography Tray Cardiovascular Class 2 870.1650 2011-11-09
OFO Airway Suction Kit Anesthesiology Class 1 868.6810 2011-11-09
OFU Spinal Anesthesia Kit Anesthesiology Class 2 868.5120 2011-11-09
MAC Decontamination Kit General, Plastic Surgery Class 1 878.4014 2011-11-11
FRO Dressing, Wound, Drug Unknown Class U N/A 2008-01-10
OFF Central Venous Catheter Tray Cardiovascular Class 2 870.1140 2011-11-09
OHO First Aid Kit Without Drug General, Plastic Surgery Class 1 878.4014 2011-11-11
OHC Obstetrical Vacuum Delivery Kit Obstetrics/Gynecology Class 2 884.4340 2011-11-14
OJW Shave Prep Kit General, Plastic Surgery Class 2 878.4370 2011-06-27
OFT Spinal Epidural Anesthesia Kit Anesthesiology Class 2 868.5120 2011-11-09
OEQ Angiography/Angioplasty Kit Cardiovascular Class 2 870.1650 2011-06-27
OKH Body Fluids Barrier Kit General, Plastic Surgery Class 2 878.4040 2011-11-10
OHL Pap Smear Kit Obstetrics/Gynecology Class 2 884.4530 2011-11-14
PXZ Laparascopic Sphincterotomy Kit General, Plastic Surgery Class 1 878.4800 2018-07-02
PYC Paracentesis Tray General, Plastic Surgery Class 1 878.4200 2018-07-02
PXN Basic Set-Up Tray General, Plastic Surgery Class 1 878.4800 2018-07-02
OGS Myringotomy Procedure Kit Ear, Nose, Throat Class 2 874.3880 2011-11-09
PYI Thoracic Catheter Insertion Tray General, Plastic Surgery Class 1 878.4200 2018-07-02
NYH Plaque Disclosing Kit Dental Class 2 872.1740 2011-11-09
OHM Cesarean Section Tray Obstetrics/Gynecology Class 2 884.1720 2011-07-19
OGC Continuous Brachial Plexus Block Tray Anesthesiology Class 2 868.5150 2011-11-09
PEV Dialysis Administration Kit Gastroenterology, Urology Class 2 876.5820 2015-06-04
PSJ Rectal Dilator Kit Gastroenterology, Urology Class 1 876.5450 2018-06-06
OES Cardiac Catheterization Kit Cardiovascular Class 2 870.1200 2011-11-09
PVO Lumbar Drainage Catheter Kit Neurology Class 2 882.5550 2018-06-06
PRY Gastrostomy Jejunostomy Feeding Tube Kit Gastroenterology, Urology Class 2 876.5980 2018-06-06
OEV Cardiopulmonary Resuscitation Aid Kit Anesthesiology Class 2 868.5915 2011-11-09
NXZ Dental Hygiene Kit Dental Class 1 872.6855 2011-11-09
OFZ Blood Specimen Collection Kit (Excludes Hiv Testing) Anesthesiology Class 1 868.1100 2011-11-09
OGE Epidural Anesthesia Kit Anesthesiology Class 2 868.5120 2011-06-27
OFA Cardiovascular Surgical Instruments Tray Cardiovascular Class 1 870.4500 2009-05-07
LRP Tray, Surgical General, Plastic Surgery Class 1 878.4800 2006-05-18
PPA Bladder Irrigation Kit Gastroenterology, Urology Class 2 876.5130 2018-03-28
OXQ Dressing Change Tray General Hospital Class 1 880.5075 2011-09-06
OHF Culdocentesis Kit Obstetrics/Gynecology Class 2 884.1640 2011-11-14
NYC Dental Prophylaxis Kit Dental Class 1 872.4565 2011-11-09
OIE Urine Collection Kit (Excludes Hiv Testing) Pathology Class 1 864.3250 2011-11-11
PZG Surgical Eye Tray Ophthalmic Class 1 886.4350 2018-07-02
PPP Disposable Joint Aspiration/Injection Kit General, Plastic Surgery Class 1 878.4800 2018-05-10
PQD Blood Specimen Collection Convenience Kit (Excludes Hiv) Clinical Chemistry Class 2 862.1675 2018-06-05
PYG Suction Catheter Kit General, Plastic Surgery Class 1 878.4200 2018-07-02
PYH Surgical Retractor Kit General, Plastic Surgery Class 1 878.4800 2018-07-02
KDD Kit, Surgical Instrument, Disposable General, Plastic Surgery Class 1 878.4800 1996-05-01
PPL Single Needle (Co-Axial Flow) Dialysis Kit Gastroenterology, Urology Class 2 876.5820 2018-05-10
MLT Pelvic Exam Kit Obstetrics/Gynecology Class 2 884.4530 2011-09-13
EBO Denture Repair Kit Dental Class 2 872.3570 2011-11-09
NWN Laparoscopic Bone Anchor Urethropexy Instrument Kit Orthopedic Class 2 888.3040 2018-03-15
PWT Chemotherapy Spill Clean-Up Kit General Hospital Class 1 880.6250 2025-12-02
OFN Winged Intravenous Catheterization Kit Cardiovascular Class 2 870.1200 2011-11-09
OGQ Ear Irrigation Kit General Hospital Class 1 880.6960 2011-11-09
NWT Endoscopic Cholangiogram Kit Gastroenterology, Urology Class 2 876.1500 2011-11-10
NWP Suprapubic Cystostomy Catheter Kit Gastroenterology, Urology Class 2 876.5090 2011-11-11
OFV Regional Anesthesia Kit Anesthesiology Class 2 868.5120 2011-11-09
OFR Tracheobronchial Suction Catheter Kit Anesthesiology Class 1 868.6810 2011-11-09
MDM Instrument, Manual, Surgical, General Use General, Plastic Surgery Class 1 878.4800 2007-08-23
OFS Tracheal Suction Set Anesthesiology Class 1 868.6810 2011-11-09
MCY Wound Dressing Kit General Hospital Class 2 880.5075 2011-11-11
PSA Laparoscopic Jejunostomy Kit Gastroenterology, Urology Class 2 876.5980 2018-06-06
OJG Neurological Tray Neurology Class 1 882.4525 2009-05-07
PWY Lumbar Puncture Tray (Adult & Pediatric) General Hospital Class 2 880.5570 2018-06-06
PXX Incision Tray General, Plastic Surgery Class 1 878.4800 2018-07-02
PVW Pudendal Anesthesia Kit Obstetrics/Gynecology Class 2 884.5100 2018-06-06
PVT Maternity Kit Obstetrics/Gynecology Class 1 884.5435 2018-06-06
PAD Chest Drainage Kit General Hospital Class 2 880.6740 2018-03-15
PXM Vomitus Clean-Up Kit General Hospital Class 1 880.6890 2018-07-02
PSD Laparoscopic Gastrostomy Kit Gastroenterology, Urology Class 2 876.5980 2018-06-06
FKG Tray, Start/Stop (Including Contents), Dialysis Gastroenterology, Urology Class 1 876.5820 1990-10-24
OFQ Anesthesia Kit Anesthesiology Class 2 868.5120 2011-11-09
PPQ Transtibial Anterior Cruciate Ligament Kit Orthopedic Class 2 888.3040 2018-06-05
KYP Snake Bite Suction Kit General Hospital Class 1 880.5740 2011-11-14
PPD Universal Drainage Tray Gastroenterology, Urology Class 2 876.5130 2018-04-30
PPK Peritoneal Dialysis Tubing Kit Gastroenterology, Urology Class 2 876.5630 2018-05-10
PPE Nephroscope Set Gastroenterology, Urology Class 2 876.1500 2018-01-24
OKU Emergency Obstetrical Kit Obstetrics/Gynecology Class 1 884.4520 2011-11-14
PYJ Ulcer Wound Tray General, Plastic Surgery Class 1 878.4014 2018-07-02
OJV Single Use Instrument Tray General, Plastic Surgery Class 1 878.4800 2011-07-07
NXA Tracheotomy Care Kit Anesthesiology Class 2 868.5800 2011-09-08
OGP Cricothyrotomy Kit Anesthesiology Class 2 868.5800 2011-11-09
OJK Eye Tray Ophthalmic Class 2 886.4790 2011-06-27
FDE Laparoscopy Kit Gastroenterology, Urology Class 2 876.1500 2011-06-27
PXY Irrigation Kit (Wounds) General, Plastic Surgery Class 1 878.4014 2018-07-02
PPC Male External Catheterization Kit (Excludes Hiv Testing) Gastroenterology, Urology Class 2 876.5130 2018-04-30
PXC Personal Protection Kit General Hospital Class 1 880.6250 2018-06-06
PPG Urinary Drainage Collection Kit Gastroenterology, Urology Class 2 876.5130 2018-04-30
OKI Emergency Response Safety Kit General, Plastic Surgery Class 2 878.4040 2011-11-11
OGL Oxygen Administration Kit Anesthesiology Class 2 868.5655 2011-11-09
OGT Oral Irrigation Kit Dental Class 1 872.6510 2011-11-09
PRW Gastrointestinal Tube Kit Gastroenterology, Urology Class 2 876.5980 2018-06-06
OKX Trocar Kit Obstetrics/Gynecology Class 2 884.1720 2011-11-14
LRQ Tracheostomy And Nasal Suctioning Kit Unknown Class 1 N/A 2011-11-09
PSK Replacement Gastrostomy Feeding Catheter Tray Gastroenterology, Urology Class 2 876.5980 2018-06-06
OGK Orotracheal Intubation Guide Kit Anesthesiology Class 2 868.1400 2011-11-09
OFW Restorative Instrument And Component Tray Dental Class 2 872.3690 2011-11-09
PPI Hemodialysis Tray (Not A Start/Stop Kit) Gastroenterology, Urology Class 2 876.5820 2018-04-30
OII Arthrogram Tray Radiology Class 2 892.1650 2011-06-27
NWI Electrosurgical Electrode Kit Gastroenterology, Urology Class 2 876.4300 2011-11-10
OVN Suture Kit General, Plastic Surgery Class 2 878.4830 2011-06-27
PYF Sterile Puncture Tray General, Plastic Surgery Class 1 878.4800 2018-07-02
NWU Endoscope Introducer Kit Gastroenterology, Urology Class 2 876.1500 2011-11-10
PXP Breast Biopsy / Localization Tray General, Plastic Surgery Class 1 878.4800 2018-07-02
PVX Vaginal Examination Tray Obstetrics/Gynecology Class 2 884.4530 2018-06-06
PXV General Purpose Instrument Tray General, Plastic Surgery Class 1 878.4800 2018-07-02
OGR Ear, Nose, And Throat Surgical Tray Ear, Nose, Throat Class 1 874.4420 2011-06-27
PXG Spill Kit General Hospital Class 1 880.6890 2018-06-06
PRP Balloon Gastrostomy Tube Kit Gastroenterology, Urology Class 2 876.5980 2018-06-05
OKZ Endometrial Sampling Kit Obstetrics/Gynecology Class 2 884.1175 2011-11-14
OFM Phlebotomy Blood Collection Kit Cardiovascular Class 2 870.2750 2011-11-09
OEX Cardiovascular Catheter Sheath Introducer Kit Cardiovascular Class 2 870.1340 2011-11-09
PXK Vascular Access Port Kit General Hospital Class 2 880.5965 2018-07-02
NYE Fixture Mount Kit Dental Class 1 872.3980 2011-11-09
MYK Kit, Cord Blood Collection Unknown Class N N/A 2013-02-01
PPF Urinary Irrigation Kit Gastroenterology, Urology Class 2 876.5130 2018-04-30
PPR Surgical Cannulaes & Depth Gauge Kit For Arthroscopic Procedures Orthopedic Class 2 888.1100 2018-06-05
PPH Single Needle With Uni-Directional Pump Kit Gastroenterology, Urology Class 2 876.5820 2018-04-30
NYG Lapping Tool Kit Dental Class 1 872.4565 2011-11-09
OFJ Lead Introducer Kit Cardiovascular Class 2 870.1340 2011-11-09
PSC Nasogastric-Gastrojejunal Kit Gastroenterology, Urology Class 2 876.5980 2018-06-06
PKD Laceration Tray General, Plastic Surgery Class 1 878.4014 2018-03-15
LWE Bone Marrow Collection/Transfusion Kit Unknown Class 2 N/A 2011-11-11
OFL Percutaneous Sheath Introducer Kit Cardiovascular Class 2 870.1340 2011-11-09
OHR Catheter Care Tray Gastroenterology, Urology Class 2 876.5130 2011-11-10
OJH Orthopedic Tray General, Plastic Surgery Class 1 878.4800 2009-05-07
PXQ Burn Dressing Tray General, Plastic Surgery Class 1 878.4022 2018-07-02
PWO Blood Administration Kit General Hospital Class 2 880.5440 2018-06-06
OKE Port Introducer Kit General Hospital Class 2 880.5965 2011-09-28
PVP Neurological Test Kit Neurology Class 1 882.1750 2018-06-06
OIL Discography Kit Radiology Class 2 892.1730 2011-11-14
OGH Laryngoscope Kit Anesthesiology Class 1 868.5540 2011-11-09
LRS I.V. Start Kit General Hospital Class 2 880.5200 2011-09-01
EXM Truss, Umbilical Gastroenterology, Urology Class 1 876.5970 2011-03-28
OGI Nasal Endotracheal Tube Holder Kit Anesthesiology Class 1 868.5770 2011-11-09
OKG Body Fluid Clean Up Kit General, Plastic Surgery Class 2 878.4040 2011-11-11
GCY Apparatus, Suction, Single Patient Use, Portable, Nonpowered General, Plastic Surgery Class 1 878.4680 2000-08-03
OGD Custom Anesthesia Tray Anesthesiology Class 2 868.5120 2011-11-09
PSI Perineal Irrigation Kit Gastroenterology, Urology Class 2 876.5980 2018-06-06
PXD Prep Kit General Hospital Class 1 880.6250 2018-06-06
OKY Cytology Kit Obstetrics/Gynecology Class 2 884.4530 2011-11-14
OGF Glossopharyngeal Anesthesia Kit Anesthesiology Class 2 868.5120 2011-11-09
OJU Skin Prep Tray General, Plastic Surgery Class 1 878.4800 2011-06-27
PRV Gastro-Urology Biopsy Kit Gastroenterology, Urology Class 2 876.1075 2018-06-05
PKE Laparoscopic Cholecystectomy Kit General, Plastic Surgery Class 1 878.4800 2018-03-15
PYD Pelviscopy Kit General, Plastic Surgery Class 1 878.4800 2018-07-02
PSP Intracranial Pressure & Temperature Monitoring Kit Neurology Class 2 882.1620 2018-06-06
PVM Endoscopic Ventricular Catheter Placement Kit Neurology Class 2 882.4100 2018-06-06
CBT Arterial Blood Sampling Kit Anesthesiology Class 1 868.1100 1993-02-05
POR Parenteral Administration Kit General Hospital Class 2 880.5440 2018-03-15
POZ Biopsy Needle Kit Gastroenterology, Urology Class 2 876.1075 2018-03-19
OGA Brachial Plexus Anesthesia Kit Anesthesiology Class 2 868.5140 2011-11-09
PRQ Esophageal Dilator Kit Gastroenterology, Urology Class 2 876.5365 2018-06-05
PXB Percutaneous Introducer Kit General Hospital Class 2 880.5570 2018-06-06
MCZ Suture Removal Kit General, Plastic Surgery Class 1 878.4800 2011-09-19
OIN Prostate Seeding Kit Radiology Class 2 892.5730 2011-11-14
POQ Blood Transfusion Kit General Hospital Class 2 880.5440 2018-03-15
PXJ Umbilical Catheter Insertion Tray General Hospital Class 2 880.5200 2018-06-06
PYL Wound Drainage Kit General, Plastic Surgery Class 1 878.4014 2018-07-02
OFB Catheter Guide Wire Kit Cardiovascular Class 2 870.1330 2011-11-09
OFG Ct Biopsy Tray Cardiovascular Class 2 870.4075 2011-11-09
OJJ Burn Kit Without Drug General, Plastic Surgery Class 1 878.4022 2011-11-11
OFK Percutaneous Atrial Catheter Kit Cardiovascular Class 2 870.1250 2011-11-09
PSB Nasogastric Feed Tube Kit Gastroenterology, Urology Class 2 876.5980 2018-06-06

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
K150256 Argentum Medical SILVERLON BURN CONTACT DRESSINGS 2015-04-30
K881095 CooperVision, Inc. KOI(TM) INSTRUMENT TRAYS 1988-04-06
K883982 Iberhospitex, S.A. DRENOVAC 1989-02-23

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0003-06 B. Braun Medical, Inc. U
D-Stat Dry Hemostatic Bandage. The product is an adhesive bandage.
Z-0038-2025 3M Company Health Care Business 3m Center U
3M Tegaderm CHG, Chlorhexidine Gluconate I.V. Securement Dressing, REF 1658R
Z-0026-2020 Merit Medical Systems, Inc. 2
Custom Procedure Kit, Custom Kit, REF/Product Code: K12T-03688, single use, RX Only, Sterile EO, LATEX FREE, UDI: (01)00884450389409
Z-0015-2009 Medline Industries Inc 2
Medline Latex Free C-Section CDS-LF and C-Section Supplemental CDS-LF; a single patient prescription procedure pack and disposables, including a Gerber Nuk Pacifier; Made in USA by Medline Industries, Inc., Mundelein, IL 60060
Z-0016-2009 Medline Industries Inc 2
Medline Latex Free Vaginal Delivery CDS-LF; a single patient prescription procedure pack and disposables, including a Gerber Nuk Pacifier; Made in USA by Medline Industries, Inc., Mundelein, IL 60060

Similar Registrations

Registration Number Establishment Name Location
1423537 Cardinal Health 200, LLC Waukegan, IL, US
1061124 Sterigenics U.S., LLC Charlotte, NC, US
9616088 Convertors de Mexico S. de R.L. de C.V CD.JUAREZ Chihuahua, MX
3004111573 Sterigenics US LLC Grand Prairie, TX, US
3009888344 Isomedix Operations Inc El Paso, TX, US
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3007329020. Last updated year: 2026. Please use registration number 3007329020 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.