FDA.reportPublic FDA data

ConvaTec

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
10003175711000317571CONVATEC LIMITED1N2026-01-01First Avenue DEESIDE INDUSTRIAL PARK Deeside Flintshire GB CH5 2NU
30119879673011987967ConvaTec, Inc.1Y2026-01-017815 National Service Road Suite 600 Greensboro NC US 27409
30128817403012881740ConvaTec Canada Ltd.1N2026-01-011425 TransCanada Highway Suite 100 Dorval Quebec CA H9P 2V3
30176607503017660750CONVATEC TRIAD LIFE SCIENCES, LLC1N2026-01-011770 Moriah Woods Blvd. Suite 18 Memphis TN US 38117

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
00768455108268STOMAHESIVE - Stomahesive® Protective Powder, 1 Oz.+18004228811cic12@convatec.com
00768455201303AVELLE - Avelle™ Negative Pressure Wound Therapy Carry Bag1-800-422-8811cic@convatec.com
00768455204670ESTEEM - N/A+18004228811cic12@convatec.com
00768455204717ESTEEM - N/A+18004228811cic12@convatec.com
00768455204724ESTEEM - N/A+18004228811cic12@convatec.com
00768455204748ESTEEM - N/A+18004228811cic12@convatec.com
00768455204755ESTEEM - N/A+18004228811cic12@convatec.com
00768455204762ESTEEM - N/A+18004228811cic12@convatec.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1860471223202219K973076EUROMEDICAL HAEMATURIA FOLEY CATHETEREZL1998-09-16
1860471902702130K965120ALLCLENZ WOUND CLEANSERKMF1997-03-21
1860471113729483K962389EUROMEDICAL REINFORCED ENDOTRACHEAL TUBEBTR1996-11-21
1860472016582059K954752PEDIATRIC EUROPHYLIC FOLEY CATHETEREZL1995-10-30
1860472001848651K951697PEDIATRIC ENDOTRACHEAL TUBEBTR1995-05-22
1860471802119416K951696ENDOTRACHEAL TUBEBTR1995-05-22
1860471226586775K945874EUROMEDICAL POLY TRACHEOTOMY TUBEJOH1994-12-27
1860471668174056K945806SILICATH ALL SILICONE FOLEY CATHETEREZL1995-03-21
1860471459039740K944007EUROPHILIC SLIPPERY COATED FOLEY CATHETEREZL1995-06-29
1860471217228519K915750DISPOSABLE BACTERIAL BREATHNG FILTERCAH1994-11-30
1860471684368274K915228DISPOSABLE CO2 GAS SAMPLING/OXYGEN DELIVERY CANNULCCK1992-02-11
1860472054476910K896734FEEDING TUBEFPD1990-12-21
1860471554131193K896729NELATON-, FEMALE - OR TIEMANN CATHETERKOD1990-11-05
1860471109876878K874517PHARMASEAL RUBBER URETHRAL CATHETERKOD1987-12-03
1860471374029343K873286DISPOSABLE, MANUAL PULMONARY RESUSCITATORBTM1987-10-26
361871897993971K862935WOUND MANAGER(TM) - STERILENAD1986-08-20
1860471897993971K862935WOUND MANAGER(TM) - STERILENAD1986-08-20
1860471519889704K842395SUR-FIT NIGHT DRAINAGE CONTAINER SETKNX1984-08-08
1860471226737647K841544AMER. PHARMASEAL SILICONIZED LATEXKOD1984-07-09
1860471395607584K832299VISI-FLOW IRRIGATOREXD1983-08-26
361871980085316K811240SUR-FIT LOOP OSTOMY O.R. SETEXB1981-06-16
1860471980085316K811240SUR-FIT LOOP OSTOMY O.R. SETEXB1981-06-16
1860471531848327K811239SUR-FIT DISPOSABLE CONVEX INSERTEXB1981-06-09
1860471565691994K811160SUR-FIT IRRIGATION SLEEVEEXD1981-06-02
1860471036121330K810200OPTIPORE SCRUB SPONGEEFQ1981-02-13
1860471206633653K791536DISPOSABLE MEDICATION NEBULIZERCAF1979-09-07
1860471742284325K770256CATHETERS, SILICONE COATEDKOD1977-02-17
1860471531414218K760372HUMIDIFIER, DISPOSABLEBTT1976-08-13
1860471179686771K250891Cure Catheter Insertion Kit (K1); Cure Catheter Insertion Kit (K2); Cure Catheter Insertion Kit (K2-90); Cure Catheter Insertion Kit (K3); Cure Hydrophilic Catheter Kit (HM12UK); Cure Hydrophilic Catheter Kit (HM14UK); Cure Hydrophilic Catheter Kit (HM16UK); Cure Pocket Catheter Kit (M14UK); Cure Catheter Closed System Kit (CS8); Cure Catheter Closed System Kit (CS10); Cure Catheter Closed System Kit (CS12); Cure Catheter Closed System Kit (CS14); Cure Catheter Closed System Kit (CS14CFCM2025-06-06
1860471191079854K250699Cure Twist Female 8 Catheter (T8); Cure Twist Female 10 Catheter (T10); Cure Twist Female 12 Catheter (T12); Cure Twist Female 14 Catheter (T14); Cure Twist Female 16 Catheter (T16); Cure Twist Female 8 Catheter Kit with supplies (T8K); Cure Twist Female 10 Catheter Kit with supplies (T10K); Cure Twist Female 12 Catheter Kit with supplies (T12K); Cure Twist Female 14 Catheter Kit with supplies (T14K); Cure Twist Female 16 Catheter Kit with supplies (T16K)EZD2025-07-01
1860471635474744K243228Flexi-Seal AIR (with ENFit Connector)KNT2025-03-28
1860471081320490K232665GentleCath Air for Women (CH10); GentleCath Air for Women (CH12); GentleCath Air for Women (CH14)EZD2024-01-25
361871808274185K230400Cure Catheter Closed System; Cure Dextra Closed SystemEZD2023-11-08
1860471808274185K230400Cure Catheter Closed System; Cure Dextra Closed SystemEZD2023-11-08
361871757976397K221593Cure Ultra Male, Cure Ultra Female, Cure Ultra PlusEZD2022-11-17
1860471757976397K221593Cure Ultra Male, Cure Ultra Female, Cure Ultra PlusEZD2022-11-17
2836811069931369K213716InnovaBurnKGN2022-09-29
1860471763827780K213283GentleCath Air for Men Hydrophilic Intermittent Urinary CatheterGBM2022-06-22
2836811960655089K211902InnovaMatrix PDKGN2022-09-28
2836811648931872K210580InnovaMatrix FSKGN2021-04-21
2836811807949189K193552InnovaMatrixKGN2020-10-21
361871623990277K190114Flexi-Seal PROTECT PLUS Fecal Management System (with ENFit Connector)KNT2019-04-30
1860471623990277K190114Flexi-Seal PROTECT PLUS Fecal Management System (with ENFit Connector)KNT2019-04-30
1997261623990277K190114Flexi-Seal PROTECT PLUS Fecal Management System (with ENFit Connector)KNT2019-04-30
1860471273045649K181206GentleCath Glide Intermittent Urinary CatheterGBM2018-08-16
1860471687694772K180205AVELLE Negative Pressure Wound Therapy SystemOMP2018-10-19
361871000402544K173675AQUACEL Ag+ EXTRA Enhanced Hydrofiber Dressing with Silver and Strengthening FiberFRO2018-07-20
1860471000402544K173675AQUACEL Ag+ EXTRA Enhanced Hydrofiber Dressing with Silver and Strengthening FiberFRO2018-07-20
1860471816367477K172924GentleCath Intermittent Urinary CatheterKOD2017-11-21
361872005630600K162906Flexi-Seal PROTECT Fecal Management SystemKNT2017-03-07
1860472005630600K162906Flexi-Seal PROTECT Fecal Management SystemKNT2017-03-07
1997262005630600K162906Flexi-Seal PROTECT Fecal Management SystemKNT2017-03-07
361871777559758K161344GentleCath Glide Intermittent CatheterKOD2016-09-20
1860471777559758K161344GentleCath Glide Intermittent CatheterKOD2016-09-20
1860471747996319K152926AQUACEL Ag Surgical SP DressingFRO2016-01-21
361871945556625K150350Flexi-Seal Signal Fecal Management SystemKNT2015-07-21
1860471945556625K150350Flexi-Seal Signal Fecal Management SystemKNT2015-07-21
1997261945556625K150350Flexi-Seal Signal Fecal Management SystemKNT2015-07-21
1860471449037304K132500CURE CATHETER FEMALE, CURE CATHETER MALE, CURE CATHETER COUDE, CURE CATHETER PEDIATRIC, CURE CATHETER HYDROPHILIC COATEDEZD2013-12-23
361871516537495K123481AQUACEL AG FOAM HYDROFIBER FOAM DRESSING WITH SILVER, ADHESIVE AND NON ADHESIVEFRO2013-06-06
1860471516537495K123481AQUACEL AG FOAM HYDROFIBER FOAM DRESSING WITH SILVER, ADHESIVE AND NON ADHESIVEFRO2013-06-06
361871114474239K121275AQUACEL AG EXTRA HYDROFIBER DRESSING WITH SILVER AND STRENGTHENING FIBERFRO2012-07-25
1860471114474239K121275AQUACEL AG EXTRA HYDROFIBER DRESSING WITH SILVER AND STRENGTHENING FIBERFRO2012-07-25
1860471664908441K120872ASANTE CONSET AND ASANTE COMFORT SUBCUTANEOUS INFUSION SETS FOR USE WITH ASANTE PEARL INFUSION PUMPSFPA2012-04-20
361871995193648K112342FLEXI-SEAL SIGNAL FECAL MANAGEMENT SYSTEMKNT2012-04-26
1860471995193648K112342FLEXI-SEAL SIGNAL FECAL MANAGEMENT SYSTEMKNT2012-04-26
1997261995193648K112342FLEXI-SEAL SIGNAL FECAL MANAGEMENT SYSTEMKNT2012-04-26
1860471424854778K110653CURE CATHETEREZD2011-08-01
1860471754780492K091034AQUACEL AG SURGICALFRO2009-12-16
361871844093946K090254SILVER IMPREGNATED HYDROFIBER DRESSING REINFORCED WITH NYLON (FLAT)FRO2009-09-04
1860471844093946K090254SILVER IMPREGNATED HYDROFIBER DRESSING REINFORCED WITH NYLON (FLAT)FRO2009-09-04
1860472015114804K080881CURE CATHETER CLOSED SYSTEMKOD2008-06-11
361871693345941K080383AQUACEL HYDROFIBER WOUND DRESSING AND AG HYDROFIBER DRESSINGFRO2008-05-02
1860471693345941K080383AQUACEL HYDROFIBER WOUND DRESSING AND AG HYDROFIBER DRESSINGFRO2008-05-02
1860471336986445K072539CURE CATHETEREZD2007-09-13
361871518845498K063271AQUACEL HYDROFIBER DRESSING AND AQUACEL AG WITH HYDROFIBER SILVER IMPREGNATED ANTIMICROBIAL DRESSINGFRO2007-04-16
1860471518845498K063271AQUACEL HYDROFIBER DRESSING AND AQUACEL AG WITH HYDROFIBER SILVER IMPREGNATED ANTIMICROBIAL DRESSINGFRO2007-04-16
1860471508716359K032734CONVATEC FECAL MANAGEMENT SYSTEMKNT2004-04-08
1997261508716359K032734CONVATEC FECAL MANAGEMENT SYSTEMKNT2004-04-08
361872054505273K013814ABSORBENT ANTIMICROBIAL WOUND DRESSINGFRO2002-06-21
1860472054505273K013814ABSORBENT ANTIMICROBIAL WOUND DRESSINGFRO2002-06-21
1860471957596625K010420RUSCH MMG/O'NEIL CATHETERFCM2001-05-09
361871372449025
1860471040252185
1860471050013298
1860471078855763
1860471084359034
1860471104077379
1860471128793855
1860471136695721
1860471157005164
1860471163806697
361871164774439
1860471164774439
361871192756328
1860471192756328
1860471225019847
1860471231780541
361871258268498
1860471258268498
361871350933909
1860471350933909
361871362325805
1860471362325805
1860471372449025
1860471374727462
361871426895164
1860471426895164
361871436005302
1860471436005302
1860471437409350
361871466573805
1860471466573805
1997261466573805
1860471507721122
1860471515507480
1860471542020585
1860471580661017
361871659894410
1860471659894410

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
FRO162018-07-20
KNT152025-03-28
EZD92025-07-01
KOD82017-11-21
KGN42022-09-29
EZL41998-09-16
BTR31996-11-21
EXB31981-06-16
FCM22025-06-06
GBM22022-06-22
NAD21986-08-20
EXD21983-08-26
OMP12018-10-19
FPA12012-04-20
KMF11997-03-21
JOH11994-12-27
CAH11994-11-30
CCK11992-02-11
FPD11990-12-21
BTM11987-10-26
KNX11984-08-08
EFQ11981-02-13
CAF11979-09-07
BTT11976-08-13

PMN#

119 records. Showing 1-40. Next

GUDID#

80 records. Showing 1-40. Next