Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

8040412

FEI Number

3009271244

Entity Name

Teleflex Medical Sdn. Bhd.

City/State/Country

KAMUNTING Perak, MY

Establishment Address

Lot PT 2577, Jalan Perusahaan 4, KAMUNTING Perak 34600, MY

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Teleflex (Owner Number: 9062981)

Owner / Operator Contact Address

3015 Carrington Mill Blvd., Morrisville, NC 27560, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K954828

PMA Number

N/A

All Registered Proprietary Names

FILTER, BACTERIAL, BREATHING-CIRCUIT Rusch Flocath Hydrophilic Intermittent Catheter, Rusch MMG Hydrophilic Intermittent Catheter RUSCH BRILLANT SILICONE FOLEY Tracheal Tube MULTIPLE URETHRAL CATHETERS Rusch MMG H2O Bladder Catheter Tiemann Rusch FloCath Quick 18 Fr. Coude Hydrophilic Intermittent Catheter Oral/Nasal Safety Clear Trache tube cuffed, magill/murphy Y Connector Elbow Connector M Connector Connector Sher-I-Swiv Double Swivel Connector CPRAM Respiratory Assist Device Hudson RCI Adaptors and Connectors Rusch Connector Oxygenator Rusch Connector Trach Tee Fitting Hudson RCI Tubing Hudson RCI Sensor Tee Rusch Connector with Barbed Elbow Nelaton catheter rubber, cylindrical / Robinson pattern / whistle tip / coaxial / Tiemann pattern Nelaton-Robinson catheter, Tiemann pattern Female catheter Nelaton-Robinson catheter, cylindrical Rusch all purpose red rubber Rusch Silicone Coated Foley, and pediatric Rusch all purpose Robinson / Nelation ERU Catheter PVC Tiemann Pattern AGT PVC Preform Oral trachea tube cuffed w/mur eye Hudson Sampling Lines and Filters Gas Sampling Lines Multiple Ventilator T Corr A Tube Smooth Flo Corr A Tube II Corr A Flex Rusch Sampling Lines, Rusch Anesthesia Circuit Accessories Catheter Mount Rusch Corrugated Tubing Venti-Comp Gibeck RCI SOFTFLEX Hudson Anesthesia Circuit Assessories Iso-Gard Filter Angled/Iso-Gard Filter Straight Standard Connector Humid Vent HEPA RuSCH SILICONE FOLEY CATHETER Teleflex Convatec GentleCath MULTIPLE STERILE URETHRAL CATHET Rusch Intermittent Insertion Kit Rusch MMG Closed System Intermittent Catheter Rusch Pocket Pac Rusch Endotracheal Tube Holder Soft Foam Mouth Cushions Trach collar Sheridan Soft-Tip Intubating Stylet Sher-I-Swiv/FO Double Swivel Connector Sheridan Sher-I-Slip Intubating Stylet Rusch Endotracheal Tube Stylet Rusch FloCath Quick kit, Female Rusch FloCath Quick Rusch Standard FloCath Flocath and Easycath Intermittent Catheter ISO-GARD HEPA FILTER-HME ISO-ARD HEPA FILTER-HME W/PORT

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
BYD	Condenser, Heat And Moisture (Artificial Nose)	Anesthesiology	Class 1	868.5375	2011-05-20
GBM	Catheter, Urethral	Gastroenterology, Urology	Class 2	876.5130	2019-12-11
KOD	Catheter, Urological	Gastroenterology, Urology	Class 2	876.5130	2019-12-11
EZL	Catheter, Retention Type, Balloon	Gastroenterology, Urology	Class 2	876.5130	2008-03-05
BTR	Tube, Tracheal (W/Wo Connector)	Anesthesiology	Class 2	868.5730	2006-05-16
GBM	Catheter, Urethral	Gastroenterology, Urology	Class 2	876.5130	2006-05-15
EZC	Catheter, Coude	Gastroenterology, Urology	Class 2	876.5130	2023-03-31
KOD	Catheter, Urological	Gastroenterology, Urology	Class 2	876.5130	2022-05-10
BTR	Tube, Tracheal (W/Wo Connector)	Anesthesiology	Class 2	868.5730	2011-04-04
BZA	Connector, Airway (Extension)	Anesthesiology	Class 1	868.5810	2006-05-16
KOD	Catheter, Urological	Gastroenterology, Urology	Class 2	876.5130	2008-09-09
BTR	Tube, Tracheal (W/Wo Connector)	Anesthesiology	Class 2	868.5730	2011-04-04
BZO	Set, Tubing And Support, Ventilator (W Harness)	Anesthesiology	Class 1	868.5975	2006-07-11
CAH	Filter, Bacterial, Breathing-Circuit	Anesthesiology	Class 2	868.5260	2012-06-24
BTR	Tube, Tracheal (W/Wo Connector)	Anesthesiology	Class 2	868.5730	2008-03-05
CAH	Filter, Bacterial, Breathing-Circuit	Anesthesiology	Class 2	868.5260	2012-12-17
EZL	Catheter, Retention Type, Balloon	Gastroenterology, Urology	Class 2	876.5130	2017-05-16
BTR	Tube, Tracheal (W/Wo Connector)	Anesthesiology	Class 2	868.5730	2006-05-16
KOD	Catheter, Urological	Gastroenterology, Urology	Class 2	876.5130	2006-05-15
FCM	Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit)	Gastroenterology, Urology	Class 2	876.5130	2006-05-15
CBH	Device, Fixation, Tracheal Tube	Anesthesiology	Class 1	868.5770	2006-05-15
BSR	Stylet, Tracheal Tube	Anesthesiology	Class 1	868.5790	2001-05-19
KOD	Catheter, Urological	Gastroenterology, Urology	Class 2	876.5130	2001-06-18
CAH	Filter, Bacterial, Breathing-Circuit	Anesthesiology	Class 2	868.5260	2012-02-10

Official Correspondent

Divya Raman

US Agent Details

Divya Raman Business: Teleflex, Inc. Email: FDA.US.Agent@Teleflex.com Phone: (612) 4231738

Related Public Records

Same Entity

Teleflex

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3013515223	T.K. India Pvt. Ltd.	Chandigarh, IN
3004365956	Teleflex Medical de Mexico, S. de R.L. de C.V.	NUEVO LAREDO Tamaulipas, MX
3010041511	Teleflex LLC (NADC)	Olive Branch, MS, US
3007134520	TELEFLEX MEDICAL	ATHLONE Westmeath, IE
3005232773	Teleflex Medical OEM LLC	Plymouth, MN, 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
K233341	Covidien, LLC	Shiley Oral/Nasal Endotracheal Tube Intermediate Cuff, Non-DEHP (87430, 87435, 87440, 87445, 87450, 87455, 87460, 87465, 87470, 87475, 87480, 87485, 87490, 87495, 87410)	2024-05-20

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.
Z-0031-2026	Percussionaire Corporation	1	Phasitron 5, IPV In-Line Valve, (Intrapulmonary Percussive Ventilation) REF: P5-TEE-20 (pack of 20)/ P5-TEE (individual) with In-Line Valve Sentec Instructions for Use

Similar Registrations

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3003898360	Teleflex Medical de Tecate, S. de R.L de C.V.	TECATE Baja California, MX
1314417	SunMed Group Holdings, LLC	Grand Rapids, MI, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 8040412. Last updated year: 2026. Please use registration number 8040412 when referencing this establishment in official correspondence.