Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3008806809

FEI Number

3008806809

Entity Name

ConvaTec Limited, GDC Building

City/State/Country

Deeside Flintshire, GB

Establishment Address

First Avenue, Deeside Industrial Park, Deeside Flintshire CH5 2NU, GB

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

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

K973076

PMA Number

N/A

All Registered Proprietary Names

GentleCath Glide Intermittent Urinary Catheter (Tiemann) GentleCath Glide Intermittent Urinary Catheter (female) GentleCath Glide Intermittent Urinary Catheter (male) Urological Catheter Smooth Bore Connector Drainage Catheter Spigot Catheter Plug Catheter Connector Visi-Flow Irrigator Visi-Flow Stoma Cone Visi-Flow Irrigation System Flexi-Seal AIR (with ENFit Connector) Flexi Seal Air Bag Unna-Flex SurePress High Compression Bandage Unna-Flex Unna Boot 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 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 Flexi-Seal SIGNAL Fecal Management System with Odor Barrier Flexi-Seal FMS Collection Bags Aquacel Ag Advantage Drain-Fix Epi-FIx Stay-Fix Cure Twist Disposable Surgical Instruments Tube Clamps Airways (Medication Nebulizer) UnoMeter Safeti Plus w/ Luer Sample Port Flexi-Seal FMS Collection Bags Flexi-Seal SIGNAL Fecal Management System Cure Hydrophilic Catheter Kit (HM16UK) Cure Catheter Insertion Kit (K2-90) Cure Catheter Insertion Kit (K1) Cure Catheter Insertion Kit (K2) Cure Hydrophilic Catheter Kit (HM14UK) Cure Catheter Closed System Kit (CS10) Cure Catheter Closed System Kit (CS14C) Cure Catheter Closed System Kit (CS14) Cure Catheter Closed System Kit (CS8) Cure Pocket Catheter Kit (M14UK) Cure Hydrophilic Catheter Kit (HM12UK) Cure Catheter Closed System Kit (CS12) Cure Catheter Insertion Kit (K3) Niko-Fix GentleCath Air for Men Natura SUR-FIT Irrigation Visi-Flow Irrigator Visi-Flow Irrigation System Visi-Flow Stoma Cone Visi-Flow Irrigator Set Asante Comfort Asante Conset DUODERM HYDROACTIVE GEL SAF-GEL Flexi-Seal FMS Collection Bags Flexi-Seal PROTECT FMS with Luer Connector Flexi-Seal PROTECT FMS with EnFit Connector Airways Suction Tip Suction Catheters Catheter and Tip ESTEEM+ Soft CONVEX ActiveLife CONVEX One-Piece Drainable Pouch with Durahesive NATURA SUR-FIT High Output Drainable Pouch SUR-FIT Plus Drainable Pouch Two-Pieces SUR-FIT NATURA Drainable Pouch STOMADRESS Plus ActiveLife One-Piece Drainable Pouch with Stomahesive SUR-FIT NATURA Stomahesive NATURA SUR-FIT Drainable Pouch with InvisiClose Outlet COMBIHESIVE 2S LITTLE ONES One-Piece Drainable Pouch AutoLock SUR-FIT Drainable Pouch LITTLE ONES Two-Pieces Adhesive Coupling Technology ESTEEM SYNERGY Drainable Pouch SUR-FIT NATURA Drainable Pouch with Filter ActiveLife One-Piece Drainable Pouch with Durahesive NATURA+ Drainable Pouch LITTLE ONES Two-Pieces Drainable Pouch ESTEEM Synergy+ Drainable Pouch ESTEEM+ Drainable Pouch ActiveLife One-Piece Drainable Pouch with Durahesive Plus Anesthesia Breathing Circuit Y-Connector Airways (Bacterial Filter) AVELLE Negative Pressure Wound Therapy System AVELLE Negative Pressure Wound Therapy Dressing 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 ABVISER Paediatric Hydrophilic Coated Foley Catheter Airways (Ventori Oxy Mask, Venturi Oxygen Mask) GentleCath Air for Men GentleCath Glide Intermittent Catheter GentleCath Air for Women HandyVac MiniVac UnoVac Siliconized Latex Foley Catheters Loop Ostomy Rod Airways (Reinforced Endotracheal Tube) Airways (Oxygen Catheter, Pharma-Plast Oxygen Catheter Urological Silicone Foley Catheter Drainage Silicone Foley Catheter 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 Airways (Mac-Safe Cannula, Oxygen Nasal Cannula) 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 GentleCath Air for Women Ventilator Circuit Ventilator Circuit IPPB Airways (Reservoir Bag, Bag, Reservoir) Cure Pediatric Catheter AQUACEL Ag Surgical SP AQUACEL Ag Advantage Surgical SP Airways (Mouthpiece) Cure Catheter Hydrophilic Coated 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 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 AQUACEL Ag Foam GentleCath Intermittent Urinary Catheter Tubing Airways Oxygen Connecting Tubes Accessories Oxygen Connecting Tubes Pressure and Accessories Urine Bags Flexi-Seal PROTECT Fecal Management System with ENFIT Flexi-Seal PROTECT Fecal Management System Flexi-Seal FMS Collection Bags SurePress Absorbent Padding AQUACEL Ag EXTRA 365-E (ADULT) 367-E (PEDIATRIC) MAC-SAFE Cure Catheter Closed System Cure Catheter Tray Haematuria Foley Catheter

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GBM	Catheter, Urethral	Gastroenterology, Urology	Class 2	876.5130	2018-08-21
GCD	Connector, Catheter	General, Plastic Surgery	Class 1	878.4200	2010-12-30
EXD	Irrigator, Ostomy	Gastroenterology, Urology	Class 2	876.5895	2016-12-19
KNT	Tubes, Gastrointestinal (And Accessories)	Gastroenterology, Urology	Class 2	876.5980	2025-09-04
PIF	Gastrointestinal Tubes With Enteral Specific Connectors	Gastroenterology, Urology	Class 2	876.5980	2025-09-04
FQM	Bandage, Elastic	General Hospital	Class 1	880.5075	1996-02-09
EZQ	Pouch, Colostomy	Gastroenterology, Urology	Class 1	876.5900	2005-06-06
NAD	Dressing, Wound, Occlusive	General, Plastic Surgery	Class 1	878.4020	2007-05-17
KNT	Tubes, Gastrointestinal (And Accessories)	Gastroenterology, Urology	Class 2	876.5980	2016-06-24
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2018-07-23
KGX	Tape And Bandage, Adhesive	General Hospital	Class 1	880.5240	1993-11-17
EZD	Catheter, Straight	Gastroenterology, Urology	Class 2	876.5130	2026-01-16
KDC	Instrument, Surgical, Disposable	General, Plastic Surgery	Class 1	878.4800	2010-12-30
FKC	Clamp, Cannula	Gastroenterology, Urology	Class 1	876.5540	2010-12-30
CAF	Nebulizer (Direct Patient Interface)	Anesthesiology	Class 2	868.5630	2010-12-30
FFG	Device, Urine Flow Rate Measuring, Non-Electrical, Disposable	Gastroenterology, Urology	Class 2	876.1800	2013-02-20
KNT	Tubes, Gastrointestinal (And Accessories)	Gastroenterology, Urology	Class 2	876.5980	2012-05-10
FCM	Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit)	Gastroenterology, Urology	Class 2	876.5130	2025-06-09
KMK	Device, Intravascular Catheter Securement	General Hospital	Class 1	880.5210	2009-04-28
GBM	Catheter, Urethral	Gastroenterology, Urology	Class 2	876.5130	2022-06-23
EXD	Irrigator, Ostomy	Gastroenterology, Urology	Class 2	876.5895	2005-06-06
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2012-05-31
NAE	Dressing, Wound, Hydrogel Without Drug And/Or Biologic	General, Plastic Surgery	Class 1	878.4022	2006-01-27
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
BYH	Drain, Tee (Water Trap)	Anesthesiology	Class 1	868.5995	2010-12-30
JOL	Catheter And Tip, Suction	General Hospital	Class 2	880.6740	2010-12-30
EXH	Bag, Urinary, Ileostomy	Gastroenterology, Urology	Class 1	876.5900	2007-05-17
CAI	Circuit, Breathing (W Connector, Adaptor, Y Piece)	Anesthesiology	Class 1	868.5240	2010-12-30
CAH	Filter, Bacterial, Breathing-Circuit	Anesthesiology	Class 2	868.5260	2010-12-30
OMP	Negative Pressure Wound Therapy Powered Suction Pump	General, Plastic Surgery	Class 2	878.4780	2018-11-02
EXG	Bag, Urine Collecting, Ureterostomy	Gastroenterology, Urology	Class 1	876.5900	2016-12-09
FEN	Device, Cystometric, Hydraulic	Gastroenterology, Urology	Class 2	876.1620	2012-10-19
EZL	Catheter, Retention Type, Balloon	Gastroenterology, Urology	Class 2	876.5130	2010-12-30
BYF	Mask, Oxygen, Low Concentration, Venturi	Anesthesiology	Class 1	868.5600	2010-12-30
EZD	Catheter, Straight	Gastroenterology, Urology	Class 2	876.5130	2026-05-27
GCY	Apparatus, Suction, Single Patient Use, Portable, Nonpowered	General, Plastic Surgery	Class 1	878.4680	2010-12-30
KOD	Catheter, Urological	Gastroenterology, Urology	Class 2	876.5130	2010-12-30
EZP	Rod, Colostomy	Gastroenterology, Urology	Class 2	876.4270	2016-12-19
BTR	Tube, Tracheal (W/Wo Connector)	Anesthesiology	Class 2	868.5730	2010-12-30
BZB	Catheter, Nasal, Oxygen	Anesthesiology	Class 1	868.5350	2010-12-30
EZL	Catheter, Retention Type, Balloon	Gastroenterology, Urology	Class 2	876.5130	2010-12-30
EXB	Collector, Ostomy	Gastroenterology, Urology	Class 1	876.5900	1996-11-19
EZP	Rod, Colostomy	Gastroenterology, Urology	Class 2	876.4270	1996-11-19
CAT	Cannula, Nasal, Oxygen	Anesthesiology	Class 1	868.5340	2010-12-30
PQE	Ostomy Care Kit	Gastroenterology, Urology	Class 1	876.5900	2016-12-14
EZD	Catheter, Straight	Gastroenterology, Urology	Class 2	876.5130	2024-02-08
BZO	Set, Tubing And Support, Ventilator (W Harness)	Anesthesiology	Class 1	868.5975	2010-12-30
BTC	Bag, Reservoir	Anesthesiology	Class 1	868.5320	2010-12-30
EZD	Catheter, Straight	Gastroenterology, Urology	Class 2	876.5130	2021-10-21
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2016-01-25
BYP	Mouthpiece, Breathing	Anesthesiology	Class 1	868.5620	2010-12-30
EZD	Catheter, Straight	Gastroenterology, Urology	Class 2	876.5130	2021-10-21
FON	Bag, Drainage, With Adhesive, Ostomy	Gastroenterology, Urology	Class 1	876.5900	2005-06-06
EZS	Appliance, Colostomy, Disposable	Gastroenterology, Urology	Class 1	876.5900	2006-01-31
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2013-06-17
KOD	Catheter, Urological	Gastroenterology, Urology	Class 2	876.5130	2018-09-06
BYX	Tubing, Pressure And Accessories	Anesthesiology	Class 1	868.5860	2010-12-30
KNX	Collector, Urine, (And Accessories) For Indwelling Catheter	Gastroenterology, Urology	Class 2	876.5250	2006-01-31
KNT	Tubes, Gastrointestinal (And Accessories)	Gastroenterology, Urology	Class 2	876.5980	2017-03-30
FRL	Fiber, Medical, Absorbent	General Hospital	Class 1	880.5300	1996-11-22
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2012-08-01
CCK	Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase	Anesthesiology	Class 2	868.1400	2013-11-20
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
OHR	Catheter Care Tray	Gastroenterology, Urology	Class 2	876.5130	2021-10-21
EZL	Catheter, Retention Type, Balloon	Gastroenterology, Urology	Class 2	876.5130	2010-12-30

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
3012881740	ConvaTec Canada Ltd.	Dorval Quebec, CA
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

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0013-2019	COVIDIEN LLC	1	Kerlix AMD Antimicrobial Bandage Roll, 6 Ply, 4-1/2 x 12.3 (11.4 cm x 3.7m), REF 3332 Product Usage- as both primary and secondary dressing containing PHMB (polyhexamethylene biguanide) to resist bacterial colonization within the dressing and bacterial penetration through the dressing.
Z-0014-2019	COVIDIEN LLC	1	Kerlix Bandage Roll, 100% Cotton, 6 Ply, Large 4-1/2 x 4-1/8 yd (11.4 cm x 3.7m), REF 6715 Product Usage: Used as both primary and secondary dressing for bandaging heads, limbs and difficult-to-dress wounds.
Z-0015-2019	COVIDIEN LLC	1	Kerlix Gauze Roll, 6 Ply, Large 4-1/2 x 4-1/8 yd (11.4 cm x 3.7m) Stretched, REF 7880 Product Usage: Used as both primary and secondary dressing for bandaging heads, limbs and difficult-to-dress wounds.
Z-0016-2019	COVIDIEN LLC	1	Kerlix Bandage Roll, 100 Cotton, 8 Ply, Large 4-1/2 x 9.3 (11.4 cm x 2.8 m), REF 6716 Product Usage: Used as both primary and secondary dressing for bandaging heads, limbs and difficult-to-dress wounds.
Z-0017-2019	COVIDIEN LLC	1	Dermacea Gauze Fluff Roll, 6 Ply, 4-1/2 x 4-1/8 yd (11.4 cm x 3.7 m), REF 441103 Product Usage: Used as both primary and secondary dressing for bandaging heads, limbs and difficult-to-dress wounds.

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9613662	MEDISCAN GMBH & CO. KG	KREMSMUNSTER Oberosterreich, AT
3008502431	HR PHARMACEUTICALS, INC d/b/a HR HealthCare	York, PA, US
1417592	MEDLINE INDUSTRIES, LP - Northfield	Northfield, IL, US
3006606901	COLOPLAST HUNGARY KFT	NYIRBATOR Szabolcs-Szatmar-Bereg, HU
3010220595	Synergy Sterilisation (M) Sdn Bhd	Kuala Ketil Kedah, MY

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008806809. Last updated year: 2026. Please use registration number 3008806809 when referencing this establishment in official correspondence.