Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3011987967

FEI Number

3011987967

Entity Name

ConvaTec, Inc.

City/State/Country

Greensboro, NC, US

Establishment Address

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

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198

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

N/A

PMA Number

N/A

All Registered Proprietary Names

Cure Ultra Tubing Airways Oxygen Connecting Tubes Accessories Oxygen Connecting Tubes Pressure and Accessories Gel Closed-System GentleCath Insertion Kit 365-E (ADULT) 367-E (PEDIATRIC) MAC-SAFE Hydrophilic Coated Foley Catheter Flexi-Seal Fecal Management System Flexi-Seal FMS Collection Bags DUOACTIVE CGF Foam Lite ConvaTec GranuFlex Signal DuoDERM CGF Border DuoDERM E Border VariHesive Signal GranuFlex Extra Thin VARIHESIVE Extra Thin DuoDERM VISIDERM DuoDerm Border DuoDERM CGF DuoDERM Extra Thin DUOACTIVE Extra Thin VariHesive Extra Thin DUOACTIVE DuoDERM Signal CGF VariHesive CGF Border DuoDERM Extra Thin CGF DuoDERM Signal GranuFlex Border DuoDERM E ConvaTec Hydrocolloid Sealing Strips GranuFlex Airways (Ventori Oxy Mask, Venturi Oxygen Mask) Paediatric Hydrophilic Coated Foley Catheter AQUACEL Ag EXTRA Suction Tip Suction Catheters Catheter and Tip GentleCath Air for Women SUR-FIT NATURA Disposable Convex Insert Visi-FLow Irrigation Adapter Faceplate SUR-FIT Plus Straight Tail Closures DuoLock Curved Tail Closure ACTIVE LIFE One-Piece Stoma Cap with Skin Barrier Visi-Flow Irrigation Sleeve Tail Closure SUR-FIT NATURA Flange Cap with Filter Visi-Flow Irrigation Sleeve DIAMONDS Gelling and Odour Control Sachets ESENTA Lubricating Deodorant NATURA Drainable Invisiclose PO Kits NATURA Stomahesive Accuseal PO Kit ESTEEM SYNERGY ESTEEM+ Drainable PO Kits NATURA Durahesive ESTEEM+ Stomahesive NATURA Stomahesive NATURA Stomahesive PO Kit SUR-FIT NATURA Drainable Pouch Stomahesive Wafer with Flexible Collar Airways (Endotracheal Tube) SENSI-CARE Adhesive Remover Wipe SENSI-CARE Adhesive Releaser Spray ESENTA Adhesive Remover Wipes AllKare ESENTA Adhesive Remover Spray Flexi-Trak Loop Ostomy Rod Cure Catheter AVELLE Negative Pressure Wound Therapy System AVELLE Negative Pressure Wound Therapy Dressing UnoMeter Safeti Plus w/ Luer Sample Port Unometer GentleCath Air for Men ESTEEM synergy Professional Kit - Loop Ostomy System NATURA Stomahesive Post Operative Surgical Ostomy System SUR-FIT Loop Ostomy Rod GentleTouch Loop Ostomy Systems - Post Operative Kits Loop Ostomy Kits Loop Ostomy Rod ESTEEM SYNERGY Professional Kit NATURA Stomahesive Skin Barrier Drainable Pouch Post Operative Kit with Loop Ostomy Rod ConvaTec Loop Ostomy Rod Drainage Catheter Urological Catheter EasiVac LITTLE ONES SUR-FIT Plus Two-Piece Close End Pouch ESTEEM Synergy+ Closed Pouch NATURA SUR-FIT Closed-End Pouch with Filter STOMADRESS Plus ACTIVE LIFE One-Piece Closed-End Pouch LITTLE ONES Two-Piece Adhesive Coupling Technology NATURA SUR-FIT Closed-End Mini Pouch NATURA SUR-FIT Closed-End Pouch SUR-FIT Plus Closed-End Pouch Two-Piece EsteemBody Closed Pouch Ostomy System SUR-FIT Plus Closed-End Pouch with Filter ESTEEM+ Soft CONVEX NATURA+ Closed Pouch ESTEEM+ Closed Pouch GentleCath Intermittent Urinary Catheter GentleCath Glide Intermittent Urinary Catheter (Tiemann) GentleCath Glide Intermittent Urinary Catheter (female) GentleCath Glide Intermittent Urinary Catheter (male) AQUACEL Ag with Strengthening Fiber AQUACEL Ag AQUACEL Ag Foam Drain-Fix Epi-FIx Stay-Fix Cure Catheter Extension Tube SUR-FIT NATURA Urostomy Pouch with Accuseal Tap NATURA+ Urostomy Pouch SUR-FIT System Night Drainage Container ACTIVE LIFE CONVEX One-Piece Urostomy Pouch Durahesive SUR-FIT NATURA Urostomy Pouch ESTEEM SYNERGY Urostomy Pouch with Accuseal Tap ACTIVE LIFE One-Piece Urostomy Pouch Durahesive EsteemBody Urostomy Pouch Ostomy System ESTEEM Urostomy Pouch SUR-FIT Plus Urostomy Pouch Two-Piece Night Drainage Container Tubing Little Ones SUR-FIT NATURA Urostomy Pouch Two-Piece Ostomy System ESTEEM+ Urostomy Pouch Durahesive ESTEEM+ Soft CONVEX LITTLE ONES One-Piece Urostomy Pouch Flexi-Seal FMS Collection Bags Flexi-Seal SIGNAL Fecal Management System Flexi-Seal FMS Collection Bags Flexi-Seal PROTECT FMS with Luer Connector Flexi-Seal PROTECT FMS with EnFit Connector Airways (Reservoir Bag, Bag, Reservoir) Airways (Warm-N-Wet HME) Silicone Coated Catheter Unna-Flex SurePress High Compression Bandage Unna-Flex Unna Boot Mucus extractors Mucus traps Suction Catheter Suction Catheter ProFlo Airways (Mac-Safe Cannula, Oxygen Nasal Cannula) Aquacel Ag Advantage DUODERM HYDROACTIVE GEL SAF-GEL SAF-Clens AF- Advanced Formula ABVISER Feeding Tube Airways (Bacterial Filter) Haematuria Foley Catheter Urine Bags Airways Urological Silicone Foley Catheter Drainage Silicone Foley Catheter SurePress Absorbent Padding Niko-Fix Forceps AQUACEL Ag Burn Airways (Disposable Anesthesia Mask) Cure Catheter Closed System Airways (Reinforced Endotracheal Tube) Visi-Flow Irrigator Visi-Flow Stoma Cone Visi-Flow Irrigation System SUR-FIT NATURA Durahesive Skin Barrier/Pouch Unit Dose Kits ESTEEM Synergy Professional Kit - Non-Sterile EsteemBody Drainable Pouch Ostomy System Eakin Fistual and Wound Pouches ESENTA Strips Esteem + Drainable Pouch Trio Diamonds GentleTouch System OR Kit - Colostomy ESTEEM+ One-Piece Pouch Stomahesive Skin Barrier Kit Natura + Drainable Pouch SUR-FIT NATURA Stomahesive Skin Barrier/Pouch Unit Dose Kits ESTEEM Synergy Professional Kit - Loop Ostomy System - Sterile NATURA Stomahesive Skin Barrier Drainable Pouch Post Operative Kit with Loop Ostomy Rod NATURA Post-Operative Kits GentleTouch System OR Kit - Ileostomy and Urostomy NATURA Drainable and Urostomy Post-Operative Kits NATURA Stomahesive CTF Skin Barrier and Urostomy Kit Cure Twist CombiDERM Non-Adhesive Sterile Dressing AQUACEL Surgical ConvaFoam Silicone ConvaFoam Border CombiDERM ACD Sterile Dressing KALTOSTAT Alginate ConvaMax SUPERABSORBER Versiva AQUACEL Burn Aquacel ConvaFiber CarboFlex Versiva XC Adhesive Versiva XC Non-adhesive ConvaFoam Non-Adhesive AQUACEL Hydrofiber AQUACEL Foam AQUACEL Extra AQUACEL Extra Hydrofiber Dressing AQUACEL Foam Pro Airways (Medication Nebulizer) Airways (Disposable Manual Pulmonary Res.) Intratracheal Pressure Sensor Flexi-Seal PROTECT Fecal Management System with ENFIT Flexi-Seal PROTECT Fecal Management System Flexi-Seal FMS Collection Bags Airways (Disposable 22 mm Adapter) Visi-Flow Irrigation Sleeve SUR-FIT Irrigation Sleeve Visi-Flow Irrigation Sleeve Tail Closure Asante Comfort Asante Conset AQUACEL Ag Advantage Surgical AQUACEL Ag Surgical Siliconized Latex Foley Catheters Airways (Bubble Humidifier) Cure Catheter Tray Non-Rebreathing Oxygen Mask Airways

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EZD	Catheter, Straight	Gastroenterology, Urology	Class 2	876.5130	2024-03-21
BYX	Tubing, Pressure And Accessories	Anesthesiology	Class 1	868.5860	2010-12-30
FCM	Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit)	Gastroenterology, Urology	Class 2	876.5130	2015-03-24
KOD	Catheter, Urological	Gastroenterology, Urology	Class 2	876.5130	2015-03-24
CCK	Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase	Anesthesiology	Class 2	868.1400	2013-11-20
EZL	Catheter, Retention Type, Balloon	Gastroenterology, Urology	Class 2	876.5130	2010-12-30
KNT	Tubes, Gastrointestinal (And Accessories)	Gastroenterology, Urology	Class 2	876.5980	2009-01-26
NAD	Dressing, Wound, Occlusive	General, Plastic Surgery	Class 1	878.4020	2007-05-17
BYF	Mask, Oxygen, Low Concentration, Venturi	Anesthesiology	Class 1	868.5600	2010-12-30
EZL	Catheter, Retention Type, Balloon	Gastroenterology, Urology	Class 2	876.5130	2010-12-30
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2012-08-01
JOL	Catheter And Tip, Suction	General Hospital	Class 2	880.6740	2010-12-30
EZD	Catheter, Straight	Gastroenterology, Urology	Class 2	876.5130	2024-02-08
EZS	Appliance, Colostomy, Disposable	Gastroenterology, Urology	Class 1	876.5900	2006-01-31
EXB	Collector, Ostomy	Gastroenterology, Urology	Class 1	876.5900	1992-11-17
PQE	Ostomy Care Kit	Gastroenterology, Urology	Class 1	876.5900	2016-12-14
BTR	Tube, Tracheal (W/Wo Connector)	Anesthesiology	Class 2	868.5730	2010-12-30
KOX	Solvent, Adhesive Tape	General, Plastic Surgery	Class 1	878.4730	1996-04-10
KGZ	Accessories, Catheter	General, Plastic Surgery	Class 1	878.4200	2007-04-24
EZP	Rod, Colostomy	Gastroenterology, Urology	Class 2	876.4270	2016-12-19
GBM	Catheter, Urethral	Gastroenterology, Urology	Class 2	876.5130	2021-10-21
EZD	Catheter, Straight	Gastroenterology, Urology	Class 2	876.5130	2021-10-21
OMP	Negative Pressure Wound Therapy Powered Suction Pump	General, Plastic Surgery	Class 2	878.4780	2018-11-02
FFG	Device, Urine Flow Rate Measuring, Non-Electrical, Disposable	Gastroenterology, Urology	Class 2	876.1800	2013-02-20
EXR	Urinometer, Mechanical	Gastroenterology, Urology	Class 2	876.1800	2010-12-30
GBM	Catheter, Urethral	Gastroenterology, Urology	Class 2	876.5130	2022-06-23
EXB	Collector, Ostomy	Gastroenterology, Urology	Class 1	876.5900	1996-11-19
EZP	Rod, Colostomy	Gastroenterology, Urology	Class 2	876.4270	1996-11-19
KOD	Catheter, Urological	Gastroenterology, Urology	Class 2	876.5130	2010-12-30
FFD	Evacuator, Bladder, Manually Operated	Gastroenterology, Urology	Class 1	876.4370	2010-12-30
EZQ	Pouch, Colostomy	Gastroenterology, Urology	Class 1	876.5900	2005-06-06
KOD	Catheter, Urological	Gastroenterology, Urology	Class 2	876.5130	2018-09-06
GBM	Catheter, Urethral	Gastroenterology, Urology	Class 2	876.5130	2018-08-21
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2010-12-28
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2013-06-17
KGX	Tape And Bandage, Adhesive	General Hospital	Class 1	880.5240	1993-11-17
NNZ	System, Urine Drainage, Closed, For Non-Indwelling Catheter, Non-Sterile	Gastroenterology, Urology	Class 1	876.5250	2021-10-21
EXG	Bag, Urine Collecting, Ureterostomy	Gastroenterology, Urology	Class 1	876.5900	2016-12-09
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	2019-11-14
PIF	Gastrointestinal Tubes With Enteral Specific Connectors	Gastroenterology, Urology	Class 2	876.5980	2019-11-14
BTC	Bag, Reservoir	Anesthesiology	Class 1	868.5320	2010-12-30
BYD	Condenser, Heat And Moisture (Artificial Nose)	Anesthesiology	Class 1	868.5375	2010-12-30
KOD	Catheter, Urological	Gastroenterology, Urology	Class 2	876.5130	2010-12-30
FQM	Bandage, Elastic	General Hospital	Class 1	880.5075	1996-02-09
BSY	Catheters, Suction, Tracheobronchial	Anesthesiology	Class 1	868.6810	2010-12-30
CAT	Cannula, Nasal, Oxygen	Anesthesiology	Class 1	868.5340	2010-12-30
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2018-07-23
NAE	Dressing, Wound, Hydrogel Without Drug And/Or Biologic	General, Plastic Surgery	Class 1	878.4022	2006-01-27
KMF	Bandage, Liquid	General Hospital	Class 1	880.5090	2018-04-11
FEN	Device, Cystometric, Hydraulic	Gastroenterology, Urology	Class 2	876.1620	2012-10-19
FPD	Tube, Feeding	Gastroenterology, Urology	Class 2	876.5980	2010-12-30
CAH	Filter, Bacterial, Breathing-Circuit	Anesthesiology	Class 2	868.5260	2010-12-30
EZL	Catheter, Retention Type, Balloon	Gastroenterology, Urology	Class 2	876.5130	2010-12-30
KNX	Collector, Urine, (And Accessories) For Indwelling Catheter	Gastroenterology, Urology	Class 2	876.5250	2006-01-31
BYH	Drain, Tee (Water Trap)	Anesthesiology	Class 1	868.5995	2010-12-30
EZL	Catheter, Retention Type, Balloon	Gastroenterology, Urology	Class 2	876.5130	2010-12-30
FRL	Fiber, Medical, Absorbent	General Hospital	Class 1	880.5300	1996-11-22
KMK	Device, Intravascular Catheter Securement	General Hospital	Class 1	880.5210	2009-04-28
HTD	Forceps	General, Plastic Surgery	Class 1	878.4800	2009-10-22
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2010-12-28
BSJ	Mask, Gas, Anesthetic	Anesthesiology	Class 1	868.5550	2010-12-30
KOD	Catheter, Urological	Gastroenterology, Urology	Class 2	876.5130	2021-10-21
FCM	Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit)	Gastroenterology, Urology	Class 2	876.5130	2021-10-21
BTR	Tube, Tracheal (W/Wo Connector)	Anesthesiology	Class 2	868.5730	2010-12-30
EXD	Irrigator, Ostomy	Gastroenterology, Urology	Class 2	876.5895	2016-12-19
FON	Bag, Drainage, With Adhesive, Ostomy	Gastroenterology, Urology	Class 1	876.5900	2005-06-06
EZD	Catheter, Straight	Gastroenterology, Urology	Class 2	876.5130	2026-01-16
NAC	Dressing, Wound, Hydrophilic	General, Plastic Surgery	Class 1	878.4018	2007-05-17
CAF	Nebulizer (Direct Patient Interface)	Anesthesiology	Class 2	868.5630	2010-12-30
BTM	Ventilator, Emergency, Manual (Resuscitator)	Anesthesiology	Class 2	868.5915	2010-12-30
BXO	Transducer, Gas Pressure	Anesthesiology	Class 1	868.2900	2015-11-23
KNT	Tubes, Gastrointestinal (And Accessories)	Gastroenterology, Urology	Class 2	876.5980	2017-03-30
BZA	Connector, Airway (Extension)	Anesthesiology	Class 1	868.5810	2010-12-30
EXD	Irrigator, Ostomy	Gastroenterology, Urology	Class 2	876.5895	2007-11-27
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2012-05-31
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2010-12-28
KOD	Catheter, Urological	Gastroenterology, Urology	Class 2	876.5130	2010-12-30
BTT	Humidifier, Respiratory Gas, (Direct Patient Interface)	Anesthesiology	Class 2	868.5450	2010-12-30
OHR	Catheter Care Tray	Gastroenterology, Urology	Class 2	876.5130	2021-10-21
KGB	Mask, Oxygen, Non-Rebreathing	Anesthesiology	Class 1	868.5570	2010-12-30

Official Correspondent

Jared Ragone

US Agent Details

No US Agent registered (Local establishment).

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
3012881740	ConvaTec Canada Ltd.	Dorval Quebec, CA
3008806809	ConvaTec Limited, GDC Building	Deeside Flintshire, GB
9618003	CONVATEC DOMINICAN REPUBLIC, INC.	Haina San Cristobal, DO

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
K142467	Abeon Medical Corporation	IntelAir Nasal Airway Support System	2014-11-24
K861213	Datex Division Instrumentarium Corp.	PB 254 IR - SPECTROMETER	1986-04-04

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0013-2012	Convatec Inc.	1	Natura Durahesive ConvaTec Moldable Technology Post-Operative /Surgical System (57 mm) Required for application to a patient immediately after ostomy surgery.
Z-0004-2013	Cure Medical LLC	2	Male, 16Fr, Straight-tip Intermittent Urinary Catheters M16. The product is distributed individually or in intermediate boxes containing 30 individual, sterile packaged catheters (PA/PE film and dialyzing paper pouches). There are 30 catheters packaged in sterile pouches that are placed into an intermediate box, 10 of these intermediate boxes packaged into one case. K072539 The Cure Catheter" device, M16, is an intermittent urinary catheter intended to be used by males for the purpose of bladder drainage. It is manufactured with conventional medical grade, latex-free, biocompatible materials. The straight-tip has been designed to eliminate trauma to the urethra and is provided in 16Fr size in an easy-to-open, sterile, single-use package. The coud-tip catheter, M16C, is designed with a curved tip that makes it easier to pass through the curvature of the prostatic urethra in men. It is also used to pass through urethral strictures. This product is prescribed for people who have difficulty or are unable to pass a straight catheter through their urethra and into their bladder.
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-0021-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	CAPNOSTREAM 20P (US) N, Part Number CS08651-01
Z-0024-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	CAPNOSTREAM 20 (US) N W/PRINTER, Part Number CS08657

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3011987967. Last updated year: 2026. Please use registration number 3011987967 when referencing this establishment in official correspondence.