Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3007134520

FEI Number

3007134520

Entity Name

TELEFLEX MEDICAL

City/State/Country

ATHLONE Westmeath, IE

Establishment Address

IDA BUSINESS AND TECHNOLOGY PARK, DUBLIN ROAD, ATHLONE Westmeath --, IE

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

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

K183461

PMA Number

N/A

All Registered Proprietary Names

EZ-BLOCKER Rusch Flocath Hydrophilic Intermittent Catheter, Rusch MMG Hydrophilic Intermittent Catheter

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
CBI	Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector)	Anesthesiology	Class 2	868.5740	2012-11-05
GBM	Catheter, Urethral	Gastroenterology, Urology	Class 2	876.5130	2019-12-11
KOD	Catheter, Urological	Gastroenterology, Urology	Class 2	876.5130	2019-12-11

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
8040412	Teleflex Medical Sdn. Bhd.	KAMUNTING Perak, MY
3005232773	Teleflex Medical OEM LLC	Plymouth, MN, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K071694	Daiken Medical Co, Ltd.	COOPDECH ENDOBRONCHIAL BLOCKER TUBE, MODELS BBT-A30XXX, BBT-B30XXX	2008-03-20
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

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
1820334	Cook Incorporated	Bloomington, IN, US
3006984712	HENAN TUOREN MEDICAL DEVICE CO., LTD.	Changyuan Henan, CN
3012307300	ICU Medical, Inc.	Minneapolis, MN, US
3004748541	Salter Labs	El Paso, TX, US
3003898360	Teleflex Medical de Tecate, S. de R.L de C.V.	TECATE Baja California, MX

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3007134520. Last updated year: 2026. Please use registration number 3007134520 when referencing this establishment in official correspondence.