Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

8040459

FEI Number

6612

Entity Name

Kendall-Gammatron Limited

City/State/Country

SAMPRAN Nakhon Pathom, TH

Establishment Address

117 MOO 2, PETCHKASEM RD., SAMPRAN Nakhon Pathom 73110, TH

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

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
FAQ	Bag, Urine Collection, Leg, For External Use, Sterile	Gastroenterology, Urology	Class 1	876.5250	1989-04-26
GAZ	Tubing, Noninvasive	General Hospital	Class 2	880.6740	2007-04-26

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
1623486	CARDINAL HEALTH 200, LLC	Jacksonville, TX, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K910471	Baxter Healthcare Corp	MEDID-VAC CLEAR NONCONDUCTIVE CONNECTING TUBE	1991-03-08

Similar Registrations

Registration Number	Establishment Name	Location
3014437893	NINGBO CHIBANDA IMP &EXP CO, LTD	Ningbo Zhejiang, CN
3014498861	ATOM HEALTH CORPORATION	Tainan City, TW
3016426851	ANHUI ARES MEDICAL TECHNOLOGY CO.,LTD.	Tianchang Anhui, CN
3013557562	CBR ENTERPRISE LIMITED	Hong Kong, HK
9710020	ZHEJIANG ANJI HUABU INDUSTRIAL CO., LTD.	HUZHOU Zhejiang, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 8040459. Last updated year: 2026. Please use registration number 8040459 when referencing this establishment in official correspondence.