CARDINAL HEALTH D.R. 203 II LTD

FDA Device Registration & Listing · SANTO DOMINGO, DO · Registration 9614277

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
9614277
FEI Number
3002692512
Entity Name
CARDINAL HEALTH D.R. 203 II LTD
City/State/Country
SANTO DOMINGO, DO
Establishment Address
ZONA FRANCA LAS AMERICAS, AUT. LAS AMERICAS , KM22 BLDG. H3-H4 South, SANTO DOMINGO --, DO
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
FYA Gown, Surgical General, Plastic Surgery Class 2 878.4040 2008-04-15
EYY Drape, Urological, Disposable General, Plastic Surgery Class 2 878.4370 2017-08-11
FYA Gown, Surgical General, Plastic Surgery Class 2 878.4040 2020-05-06
LYU Accessory, Surgical Apparel General, Plastic Surgery Class 1 878.4040 2020-05-06
ILG Stocking, Elastic Physical Medicine Class 1 890.3475 2003-07-01
HMT Drape, Patient, Ophthalmic General, Plastic Surgery Class 2 878.4370 2016-04-14
PUI Drape, Surgical, Exempt General, Plastic Surgery Class 2 878.4370 2017-08-08
KME Bedding, Disposable, Medical General Hospital Class 1 880.6060 2001-08-10

Official Correspondent

No official correspondent registered.

US Agent Details

Stacey Henning Email: stacey.henning@cardinalhealth.com Phone: (312) 2702081

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
K892118 Paramount Products, Inc. NON-STERILE MASKS AND CAPS 1989-04-20

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9614277. Last updated year: 2026. Please use registration number 9614277 when referencing this establishment in official correspondence.
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