Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

8040607

FEI Number

3002806591

Entity Name

BARD SDN. BHD.

City/State/Country

KULIM Kedah, MY

Establishment Address

LOT 57-C, KULIM INDUSTRIAL ESTATE, KULIM Kedah 09000, MY

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

C. R. Bard, Inc. (Owner Number: 2212754)

Owner / Operator Contact Address

1 Becton Drive, Franklin Lakes, NJ 07417, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Bard Red Rubber Utility Catheter SureStep Intermittent Catheter Tray Hydrogel/Silver-Coated Foley Cath & Foley Tray (I.C.) Bardex I.C. Foley Catheter (offered in strips and trays) PTFE Coated Foley Catheter w/ urine collection bag LubriSil Foley Catheter w/ collection bag PTFE Coated Foley Catheter w/ Leg Bag Hydrogel Coated Foley Catheter with Leg Bag Silicone Catheter Tray with Accessories including Leg Bag Hydrogel Coated Foley Catheter with Urine Collection Bag LubriSil Foley Catheter with Leg Bag Bard Foley Tray with Bardex All Silicone Foley Catheter (for Canada) PTFE Coated Foley Catheter w/ Urine Meter SureStep Foley Tray System Bardex All- Silicone Foley Catheter Tray (for Canada) Silicone Catheter Tray with accessories LubriSil Foley Catheter with urine collection bag Silicone Foley Catheter w/ urine collection bag PTFE Coated Foley Catheter w/ Bed Bag Hydrogel Coated Foley Catheter w/ urine collection container LubriSil Foley Catheter w/ urine collection container PTFE Coated Foley Catheter w/ urine collection container SureStep Foley Tray System Lubri-Sil Complete Care (for Canada) Bard Urine Meter Foley Tray With Bardex All-Silicone Foley Catheter (for Canada) SureStep Foley Tray System Bard Lubri-Sil Foley Catheter Tray (for Canada) SureStep Foley Tray System Bard All Silicone Foley Catheter Tray (for Canada) Coude Tip Temperature-Sensing Cath CritiCore (Coude) Foley Tray Loc-Strap Bard Male External Catheter (OTC) Bard Infection Control Urinary Needleless Sample Port Control Fit Urine Collection Container - bag/urinary drainage unit Bard Deluxe Dispoz-A-Bag Drainage Bag (Leg Bag) Urinary Drainage Unit(urinary leg Urotrack Plus (Model 220) Bard Leg Bag Holder w/ accessories) Bed Bag SureStep Foley Tray System Add-A-Foley Catheter (for Canada) Bard Foley Catheterization Tray Uro-Prep Tray (for Canada) SureStep Foley Tray System Complete Care Add-A-Foley Catheter (for Canada) Bard Standard Latex Free Foley Tray without Catheter (for Canada) Bard Male External Latex Disposable Catheter Bardia Foley Catheter Insertion w/o Catheter with Lubricant in SureStep Intermittent Catheter Tray Bard® Universal Catheterization Tray Bardia Urethral Catheter Tray 5cc Balloon w/o Catheter w/o Catheter Foley Catheter Insertion Tray for 30cc Balloon w/o Catheter Bard Foley Catheterization Tray All-Silicone Foley Catheter Lubri-Sil Foley Catheter (offered in strips and trays) Lubri-Sil I.C. Foley Catheter (offered in strips and trays) Bardex Silicone Foley Catheter (offered in strips and trays) Rubber Utility Catheter Bard Red Rubber Utility Catheter SureStep Intermittent Catheter Tray Vacuum Tubing Patient Tubing PureWick FEC Collection Canister PureWick Urine Collection Accessories Kit PureWick Urine Collection System PureWick MEC PureWick Male External Catheter PureWick Female External Catheter Bardex I.C. Pediatric Foley Cath I.C. Foley Catheter with Urine Collection Container I.C. Foley Catheter AquaFil Foley Catheter with Syringe Foley Catheter with AquaFil Magic3 Touchless Hydrophilic Intermittent Catheter System (for Canada) SureStep Foley Tray System Bardex IC Complete Care (for Canada) Lubri-Sil I.C. Complete Care Urine Meter Foley Tray (for Canada) SureStep Foley Tray System Bardex I.C. Complete Care Foley Catheter (for Canada) SureStep Foley Tray System Lubri-Sil IC Complete Care (for Canada) Touchless II Pre-Lubricated Urethral Kit Bardex Pezzers Bardex Nephrostomy Bardex Angel Drain Bardex Malecot Latex Foley Catheter with 30cc Preformed Balloon Bardia Foley Catheter Bard Lubricath Foley Catheter Hydrogel-Coated Foley Catheter Funnel Stomach/Intestinal Tube with Bulb Latex Foley Catheter & Drains Bardex Councill Model Foley Catheter Percutaneous Nephrostomy Bardex Nephrostomy Short Tip Councill Model Foley Catheter with Heyman Stylet Lubricath Foley Catheter (offered in strips and trays) Bardia Foley Catheter Bard Lubricath Foley Catheter Bard Urologist Tray Bard Urologist Tray (for Canada) Hydrogel-Coated Urethral Catheter Silastic Brand Foley Catheter Bard® Silastic® Foley Catheter Bardex I.C. 4-Way Foley Catheter Latex Foley Catheter Bardex I.C. Foley Catheter (offered in strips and trays)

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KOD	Catheter, Urological	Gastroenterology, Urology	Class 2	876.5130	2007-12-12
MJC	Catheter, Urological (Antimicrobial) And Accessories	Gastroenterology, Urology	Class 2	876.5130	2007-12-07
EZL	Catheter, Retention Type, Balloon	Gastroenterology, Urology	Class 2	876.5130	2018-01-25
EZC	Catheter, Coude	Gastroenterology, Urology	Class 2	876.5130	2007-03-14
KNX	Collector, Urine, (And Accessories) For Indwelling Catheter	Gastroenterology, Urology	Class 2	876.5250	2007-02-27
EZL	Catheter, Retention Type, Balloon	Gastroenterology, Urology	Class 2	876.5130	2007-12-07
KOD	Catheter, Urological	Gastroenterology, Urology	Class 2	876.5130	2026-02-25
NZU	Collector, Urine, Powered, Non Indwelling Catheter	Gastroenterology, Urology	Class 1	876.5250	2018-01-10
MJC	Catheter, Urological (Antimicrobial) And Accessories	Gastroenterology, Urology	Class 2	876.5130	2007-12-07
KOD	Catheter, Urological	Gastroenterology, Urology	Class 2	876.5130	2007-12-07
MJC	Catheter, Urological (Antimicrobial) And Accessories	Gastroenterology, Urology	Class 2	876.5130	2018-01-25
FCM	Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit)	Gastroenterology, Urology	Class 2	876.5130	2007-03-14
FEW	Catheter, Malecot	Gastroenterology, Urology	Class 2	876.5090	2007-12-10
KOD	Catheter, Urological	Gastroenterology, Urology	Class 2	876.5130	2007-12-07
EZC	Catheter, Coude	Gastroenterology, Urology	Class 2	876.5130	2007-12-07
KNT	Tubes, Gastrointestinal (And Accessories)	Gastroenterology, Urology	Class 2	876.5980	2007-12-11
EZC	Catheter, Coude	Gastroenterology, Urology	Class 2	876.5130	2007-12-13
EZC	Catheter, Coude	Gastroenterology, Urology	Class 2	876.5130	2007-12-07
EZL	Catheter, Retention Type, Balloon	Gastroenterology, Urology	Class 2	876.5130	2007-03-14
MJC	Catheter, Urological (Antimicrobial) And Accessories	Gastroenterology, Urology	Class 2	876.5130	2007-12-07
MJC	Catheter, Urological (Antimicrobial) And Accessories	Gastroenterology, Urology	Class 2	876.5130	2007-02-27

Official Correspondent

No official correspondent registered.

US Agent Details

Joni Anderson Email: joni.anderson@bd.com Phone: (480) 2662981

Related Public Records

Same Entity

C. R. Bard, Inc.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
1725056	MEDIVANCE, INC.	LOUISVILLE, CO, US
3006513822	Lutonix, Inc.	Tempe, AZ, US
1223089	DAVOL INC.	WOBURN, MA, US
3002504068	Bard European Distribution Center NV	Olen Antwerpen, BE
1213643	DAVOL INC., SUB. C.R. BARD, INC.	Warwick, RI, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K033719	C.R. Bard, Inc.	BARD TIGERTAIL URETERAL CATHETER	2004-02-04
K820239	American Endoscopy, Inc.	RETRIEVAL FORCEPS	1982-03-26
K041243	Tyco Healthcare	DOVER RED RUBBER ROBINSON CATHETER	2004-07-07
K233013	Silq Technologies Corporation	2-Way 100% Silicone Cleartract Catheter	2024-01-23
K791969	Medline Industries, Inc.	DYNACOR STERILE CLOSED SYS. DRAINAGE BAG	1979-11-05

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0010-2013	C.R. Bard, Inc., Urological Division	2	8 Fr. Bardex Pediatric All-Silicone Foley Catheter with a 3cc balloon. The product is packaged individually with 12 units per corrugated case. The product is sold sterile for single use and is used to provide continuous urinary drainage from the bladder.

Similar Registrations

Registration Number	Establishment Name	Location
3011987967	ConvaTec, Inc.	Greensboro, NC, US
3009504230	Sterigenics Radiation Technologies IN, Inc	Columbia City, IN, US
3007829657	ROBLING MEDICAL, LLC	Youngsville, NC, US
3030733800	AD SUPPLY GROUP LIMITED	London London, City of, GB
3013517171	KM Medical	North York Ontario, CA

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 8040607. Last updated year: 2026. Please use registration number 8040607 when referencing this establishment in official correspondence.