BEUDAMED
    FDA Registration Active 🇺🇸 United States

    ConvaTec, Inc.

    Reg #: 3011987967 · FEI: 3011987967 · Expires 2026
    View on FDA
    Products
    70
    Proprietary Names
    327
    Establishment Types
    2
    Classifications
    70

    Registration Details

    Registration Name
    ConvaTec, Inc.
    Registration Number
    3011987967
    FEI Number
    3011987967
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    7815 National Service Road, Suite 600
    City
    Greensboro
    State
    NC
    ZIP
    27409
    Country
    US

    Regulatory Submissions

    510(k) Number
    K221593

    Owner / Operator

    Firm Name
    ConvaTec
    Operator Number
    2241599
    Address
    7815 National Service Road, Suite 600
    City
    Greensboro
    State
    NC
    Postal Code
    27409
    Country
    US
    Correspondent
    Jared Ragone

    Products

    Device Name Product Code
    Catheter, Straight EZD
    Tubing, Pressure And Accessories BYX
    Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit) FCM
    Catheter, Urological KOD
    Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase CCK
    Catheter, Retention Type, Balloon EZL
    Tubes, Gastrointestinal (And Accessories) KNT
    Dressing, Wound, Occlusive NAD
    Mask, Oxygen, Low Concentration, Venturi BYF
    Dressing, Wound, Drug FRO
    Catheter And Tip, Suction JOL
    Appliance, Colostomy, Disposable EZS
    Collector, Ostomy EXB
    Ostomy Care Kit PQE
    Tube, Tracheal (W/Wo Connector) BTR
    Solvent, Adhesive Tape KOX
    Accessories, Catheter KGZ
    Rod, Colostomy EZP
    Catheter, Urethral GBM
    Negative Pressure Wound Therapy Powered Suction Pump OMP
    Device, Urine Flow Rate Measuring, Non-Electrical, Disposable FFG
    Urinometer, Mechanical EXR
    Evacuator, Bladder, Manually Operated FFD
    Pouch, Colostomy EZQ
    Tape And Bandage, Adhesive KGX
    System, Urine Drainage, Closed, For Non-Indwelling Catheter, Non-Sterile NNZ
    Bag, Urine Collecting, Ureterostomy EXG
    Gastrointestinal Tubes With Enteral Specific Connectors PIF
    Bag, Reservoir BTC
    Condenser, Heat And Moisture (Artificial Nose) BYD
    Bandage, Elastic FQM
    Catheters, Suction, Tracheobronchial BSY
    Cannula, Nasal, Oxygen CAT
    Dressing, Wound, Hydrogel Without Drug And/Or Biologic NAE
    Bandage, Liquid KMF
    Device, Cystometric, Hydraulic FEN
    Tube, Feeding FPD
    Filter, Bacterial, Breathing-Circuit CAH
    Collector, Urine, (And Accessories) For Indwelling Catheter KNX
    Drain, Tee (Water Trap) BYH
    Fiber, Medical, Absorbent FRL
    Device, Intravascular Catheter Securement KMK
    Forceps HTD
    Mask, Gas, Anesthetic BSJ
    Irrigator, Ostomy EXD
    Bag, Drainage, With Adhesive, Ostomy FON
    Dressing, Wound, Hydrophilic NAC
    Nebulizer (Direct Patient Interface) CAF
    Ventilator, Emergency, Manual (Resuscitator) BTM
    Transducer, Gas Pressure BXO
    Connector, Airway (Extension) BZA
    Set, Administration, Intravascular FPA
    Humidifier, Respiratory Gas, (Direct Patient Interface) BTT
    Catheter Care Tray OHR
    Mask, Oxygen, Non-Rebreathing KGB
    Clamp, Cannula FKC
    Stylet, Tracheal Tube BSR
    Mouthpiece, Breathing BYP
    Bag, Urinary, Ileostomy EXH
    Set, Tubing And Support, Ventilator (W Harness) BZO
    Instrument, Surgical, Disposable KDC
    Catheter, Nasal, Oxygen BZB
    Bandage, Liquid, Skin Protectant NEC
    Cement, Stomal Appliance, Ostomy EZR
    Circuit, Breathing (W Connector, Adaptor, Y Piece) CAI
    Apparatus, Suction, Single Patient Use, Portable, Nonpowered GCY
    Connector, Catheter GCD
    Protector, Ostomy EXE
    Mask, Oxygen BYG
    Tube Tracheostomy And Tube Cuff JOH

    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 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 LITTLE ONES One-Piece Urostomy Pouch Flexi-Seal SIGNAL Fecal Management System 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 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 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 Airways (Disposable 22 mm Adapter) SUR-FIT Irrigation Sleeve 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 Paediatric Endotracheal Tube 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) Tube Clamps Flexi-Seal SIGNAL Fecal Management System with Odor Barrier Airways (Endotracheal Tube Airways (Mouthpiece) AQUACEL Ag Surgical SP AQUACEL Ag Advantage Surgical SP 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 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 Ventilator Circuit Ventilator Circuit IPPB Disposable Surgical Instruments Airways (Oxygen Catheter, Pharma-Plast Oxygen Catheter SENSI-CARE Skin Barrier Foam Applicators ESENTA Sting Free Skin Barrier Wipes SENSI-CARE Skin Barrier Wipes Trio Silesse ESENTA Sting Free Skin Barrier Pump Spray SENSI-CARE Skin Barrier Spray ESENTA Sting Free Skin Barrier Spray ESENTA Sting Free Skin Barrier Foam Applicators Ostomy Appliance Belt Anesthesia Breathing Circuit Y-Connector HandyVac MiniVac UnoVac Smooth Bore Connector Spigot Catheter Plug Catheter Connector Natura SUR-FIT Irrigation Visi-Flow Irrigator Set Cure Closed System Cure Dextra Cure Pediatric Catheter Esenta Stomahesive Protective Powder ESTEEM SYNERGY Durahesive Moldable Convex with Flexible Collar NATURA Stomahesive Moldable NATURA SUR-FIT Durahesive Wafer SUR-FIT Plus Stomahesive Wafer Two-Piece NATURA Durahesive Moldable LITTLE ONES Two Piece Stomahesive with Flexible collar NATURA SUR-FIT Stomahesive Wafer with Flexible Collar NATURA Durahesive Accordion Flange SENSI-CARE Barrier Wipes NATURA SUR-FIT Durahesive Moldable Convex with Flange SUR-FIT Plus Stomahesive Wafer NATURA Stomahesive Accordion Flange AutoLock SUR-FIT Stomahesive FLEXIBLE Wafer ESTEEM SYNERGY Stomahesive ESTEEM SYNERGY Stomahesive Moldable NATURA SUR-FIT Durahesive with Convex-It Wafer with Convexity ESTEEM SYNERGY Stomahesive with Flexible Collar NATURA SUR-FIT Stomahesive Wafer ESENTA Barrier Pump Spray NATURA Durahesive Moldable Accordion Flange LITTLE ONES Two-Piece Adhesive Stomahesive with Flexible Hydrocolloid Collar Stomahesive Paste EASE Strips ESENTA Barrier Spray ESENTA Barrier Wipes Stomahesive Strips SUR-FIT Plus Stomahesive Wafer with Flexible Collar Stomahesive Powder AutoLock SUR-FIT Durahesive FLEXIBLE Wafer Stomahesive Seal NATURA SUR-FIT Durahesive Flexible Wafer with Flexible Collar SUR-FIT Plus Durahesive with Convex-It Wafer LITTLE ONES Two-Piece Adhesive Stomahesive SENSI-CARE Barrier Spray Stomahesive Wafer NATURA Stomahesive Moldable Accordion Flange SUR-FIT NATURA Moldable Stomahesive with Hydrocolloid Flexible Collar Esenta Stomahesive Paste Esenta Stomahesive Seal Rubber Urethral Catheter Cure Catheter Hydrophilic Coated GentleCath Glide Airways (Oxygen Mask) Airways (Tracheostomy Tube) Flexi-Seal AIR (with ENFit Connector) Flexi Seal Air Bag

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Develop Specifications But Do Not Manufacture At This Facility