Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3012881740

FEI Number

3012881740

Entity Name

ConvaTec Canada Ltd.

City/State/Country

Dorval Quebec, CA

Establishment Address

1425 TransCanada Highway, Suite 100, Dorval Quebec H9P 2V3, CA

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device

Owner / Operator

ConvaTec (Owner Number: 2241599)

Owner / Operator Contact Address

7815 National Service Road, Suite 600, Greensboro, NC 27409, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K032734

PMA Number

N/A

All Registered Proprietary Names

Flexi-Seal PROTECT Fecal Management System with ENFIT Flexi-Seal PROTECT Fecal Management System Flexi-Seal FMS Collection Bags Flexi-Seal FMS Collection Bags Flexi-Seal SIGNAL Fecal Management System Flexi-Seal SIGNAL Fecal Management System with Odor Barrier Flexi-Seal FMS Collection Bags Flexi-Seal FMS Collection Bags Flexi-Seal PROTECT FMS with Luer Connector Flexi-Seal PROTECT FMS with EnFit Connector Flexi-Seal Fecal Management System Flexi-Seal FMS Collection Bags

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KNT	Tubes, Gastrointestinal (And Accessories)	Gastroenterology, Urology	Class 2	876.5980	2017-03-30
KNT	Tubes, Gastrointestinal (And Accessories)	Gastroenterology, Urology	Class 2	876.5980	2012-05-10
KNT	Tubes, Gastrointestinal (And Accessories)	Gastroenterology, Urology	Class 2	876.5980	2016-06-24
KNT	Tubes, Gastrointestinal (And Accessories)	Gastroenterology, Urology	Class 2	876.5980	2019-11-14
PIF	Gastrointestinal Tubes With Enteral Specific Connectors	Gastroenterology, Urology	Class 2	876.5980	2019-11-14
KNT	Tubes, Gastrointestinal (And Accessories)	Gastroenterology, Urology	Class 2	876.5980	2009-01-26

Official Correspondent

Jared Ragone

US Agent Details

Courtney Smith Business: ConvaTec Email: courtney.smith@convatec.com Phone: (603) 2470255

Related Public Records

Same Entity

ConvaTec

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3005778470	UNOMEDICAL S.R.O.	MICHALOVCE Kosicky, SK
1000317571	CONVATEC LIMITED	Deeside Flintshire, GB
3008806809	ConvaTec Limited, GDC Building	Deeside Flintshire, GB
9618003	CONVATEC DOMINICAN REPUBLIC, INC.	Haina San Cristobal, DO
3011987967	ConvaTec, Inc.	Greensboro, NC, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K900590	Biosearch Medical Products, Inc.	BIOSEARCH DOBBHOFF(R) GASTROTRAC JEJUNAL FEEDING	1990-08-02
K102548	Footprint Medical, Inc.	FOOTPRINT MEDICAL POLYURETHANE FEEDING TUBE	2010-11-26
K955248	United States Endoscopy Group, Inc.	U.S. ENDOSCOPY PULL PEG KIT & U.S. ENDOSCOPY GUIDEWIRE PEG KIT	1996-05-21
K872921	Medical Support, Inc.	MSS ENTERAL DELIVERY SET	1987-12-03
K180622	Covidien	Kangaroo Gastrostomy Feeding Tube with ENFit Y-Port	2018-10-23

Similar Registrations

Registration Number	Establishment Name	Location
3025772870	ENTERAL ACCESS TECHNOLOGIES, LTD.	Caerwys Flintshire, GB
3015237508	ADVANCED MEDICAL BALLOONS GMBH	Waghaeusel Baden-Wurttemberg, DE
3009247326	Jabil Circuit (Singapore) Pte Ltd	Singapore Central Singapore, SG
2528981	LYNX Medical Pennsylvania	ERIE, PA, US
1649518	Sterigenics US LLC	Fort Worth, TX, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3012881740. Last updated year: 2026. Please use registration number 3012881740 when referencing this establishment in official correspondence.