BEUDAMED
    FDA Registration Active 🇺🇸 United States

    C.R. BARD, INC.

    Reg #: 1018233 · FEI: 1018233 · Expires 2026
    View on FDA
    Products
    164
    Proprietary Names
    585
    Establishment Types
    6
    Classifications
    164

    Registration Details

    Registration Name
    C.R. BARD, INC.
    Registration Number
    1018233
    FEI Number
    1018233
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    8195 INDUSTRIAL BLVD.
    City
    COVINGTON
    State
    GA
    ZIP
    30014
    Country
    US

    Regulatory Submissions

    510(k) Number
    K070558

    Owner / Operator

    Firm Name
    C. R. Bard, Inc.
    Operator Number
    2212754
    Address
    1 Becton Drive
    City
    Franklin Lakes
    State
    NJ
    Postal Code
    07417
    Country
    US

    Products

    Device Name Product Code
    Instrument, Biopsy KNW
    Hemostatic Wound Dressing Without Thrombin Or Other Biologics QSY
    Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days LJS
    Catheter, Angioplasty, Peripheral, Transluminal LIT
    Catheter, Urological (Antimicrobial) And Accessories MJC
    Catheter, Retention Type, Balloon EZL
    Set, Administration, Intravascular FPA
    Infusion Safety Management Software PHC
    Probe, Thermodilution KRB
    Collector, Urine, (And Accessories) For Indwelling Catheter KNX
    Prosthesis, Vascular Graft, Of 6mm And Greater Diameter DSY
    Balloon Aortic Valvuloplasty OZT
    Mesh, Surgical, Non-Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator PAG
    Introducer, Catheter DYB
    Catheters, Suction, Tracheobronchial BSY
    Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator OTN
    Apparatus, Suction, Single Patient Use, Portable, Nonpowered GCY
    Shunt, Peritoneal KPM
    Stylet For Catheter, Gastro-Urology EZB
    Non-Coring (Huber) Needle PTI
    Suprapubic Catheter Accessories QGC
    Container, Specimen, Non-Sterile NNI
    Catheter And Tip, Suction JOL
    Kit, Repair, Catheter, Hemodialysis NFK
    Catheter, Percutaneous, Cutting/Scoring PNO
    Clamp, Penile FHA
    Needle, Catheter GCB
    Catheter, Nephrostomy LJE
    Adaptor, Catheter GCE
    Needle, Hypodermic, Single Lumen FMI
    Electrode, Electrosurgical, Active, Urological FAS
    Filiform And Filiform Follower FBW
    Powered Laser Surgical Instrument GEX
    Midline Catheter PND
    Clamp, Cannula FKC
    Collector, Ostomy EXB
    Catheter, Coude EZC
    Catheter, Continuous Flush KRA
    Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days FOZ
    Wire, Guide, Catheter DQX
    Transducer, Ultrasonic, Diagnostic ITX
    Catheter, Hemodialysis, Implanted MSD
    Port & Catheter, Implanted, Subcutaneous, Intravascular LJT
    Instrument, Manual, Surgical, General Use MDM
    Apparatus, Suction, Patient Care DWM
    Catheter, Urological KOD
    Endoscopic Irrigation/Suction System OCX
    Tube, Double Lumen For Intestinal Decompression And/Or Intubation FEG
    Transducer, Pressure, Catheter Tip DXO
    Biliary Catheter For Irrigation And Contrast Injection, Exempt PTT
    Bag, Bile Collecting EXF
    Holder, Ureteral Catheter EYJ
    Catheter, Intravascular, Diagnostic DQO
    Catheter, Flow Directed DYG
    Catheter, Oximeter, Fiber-Optic DQE
    Staple, Implantable GDW
    Collector, Urine, Pediatric, For Indwelling Catheter FFH
    Catheter, Embolectomy DXE
    Mesh, Surgical, Polymeric FTL
    Marker, Radiographic, Implantable NEU
    Adjunctive Open Loop Fluid Therapy Recommender QMS
    Computer, Diagnostic, Programmable DQK
    Continuous Measurement Thermometer FLL
    System, Measurement, Blood-Pressure, Non-Invasive DXN
    Adjunctive Predictive Cardiovascular Indicator QAQ
    Oximeter, Tissue Saturation MUD
    Plethysmograph, Impedance DSB
    Device, Fixation, Tracheal Tube CBH
    Bone Marrow Collection/Transfusion Kit LWE
    Catheter, Straight EZD
    Fluid Drainage Tray PXU
    Tube, Nasogastric BSS
    Guide, Needle, Surgical GDF
    Dilator, Urethral KOE
    Accessories, Catheter, G-U KNY
    Stent, Ureteral FAD
    System, Applicator, Radionuclide, Manual IWJ
    Instrument, Surgical, Disposable KDC
    Thoracentesis Tray PXI
    Peritoneal, Drainage Catheter For Refractory Ascites, Long-Term Indwelling PNG
    Sealant, Polymerizing NBE
    Electrode, Pacemaker, Temporary LDF
    Device, Cystometric, Hydraulic FEN
    Catheter, Percutaneous DQY
    Biopsy Needle FCG
    Catheter, Electrode Recording, Or Probe, Electrode Recording DRF
    Syringe, Balloon Inflation MAV
    Dilator, Catheter, Ureteral EZN
    Laparoscope, General & Plastic Surgery GCJ
    Bag, Urine Collection, Leg, For External Use, Sterile FAQ
    Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Female, Mini-Sling PAH
    Catheter, Hemodialysis, Non-Implanted MPB
    Bag, Ice KYR
    Catheter, Hemodialysis, Triple Lumen, Non-Implanted NIE
    Bag, Urine Collection, Leg, For External Use, Non-Sterile NNW
    Tubes, Gastrointestinal (And Accessories) KNT
    Collector, Urine, Powered, Non Indwelling Catheter NZU
    Airway, Nasopharyngeal BTQ
    Container, Liquid Medication, Graduated KYW
    Transducer, Blood-Pressure, Extravascular DRS
    Tape And Bandage, Adhesive KGX
    Electrosurgical, Cutting & Coagulation & Accessories GEI
    System, Thermal Regulating DWJ
    Urine Collection Kit (Excludes Hiv Testing) OIE
    Tube, Tracheal (W/Wo Connector) BTR
    Dermatome GFD
    Urinometer, Electrical EXS
    Forceps HTD
    Catheter, Urethral GBM
    Needle, Aspiration And Injection, Disposable GAA
    Mesh, Surgical, Non-Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed PAI
    Mesh, Surgical, Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed OTP
    Device, Percutaneous Retrieval MMX
    Catheter, Malecot FEW
    Device, Incontinence, Urosheath Type, Non-Sterile NNX
    Evacuator, Gastro-Urology KQT
    Endoscopic Access Overtube, Gastroenterology-Urology FED
    Adaptor, Ureteral Catheter EYI
    Cable, Transducer And Electrode, Patient, (Including Connector) DSA
    Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene DXZ
    Cannula And Trocar, Suprapubic, Non-Disposable FBM
    Intra-Abdominal Pressure Monitoring Device PHU
    Tray, Surgical, Needle FSH
    Mesh, Surgical FTM
    Dislodger, Stone, Basket, Ureteral, Metal FFL
    Non-Stainless Steel Needle PVZ
    Catheter, Irrigation GBX
    Device, Urine Flow Rate Measuring, Non-Electrical, Disposable FFG
    Filter, Intravascular, Cardiovascular DTK
    Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit) FCM
    Clip, Implantable FZP
    Guide, Surgical, Instrument FZX
    Catheter For Crossing Total Occlusions PDU
    Clamp, Vascular DXC
    Urinary Drainage Collection Kit, For Indwelling Catheter FCN
    Dilator, Vessel FKA
    Mesh, Surgical, Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed OTO
    Prosthesis, Vascular Graft, Of Less Then 6mm Diameter DYF
    Dressing Change Tray OXQ
    Dilator, Vessel, For Percutaneous Catheterization DRE
    Computer, Diagnostic, Pre-Programmed, Single-Function DXG
    Device, Intravascular Catheter Securement KMK
    Stylet, Ureteral EYA
    Catheter, Intravascular Occluding, Temporary MJN
    Dressing, Wound, Occlusive NAD
    Bandage, Liquid, Skin Protectant NEC
    Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection GCA
    Pulmonary (Pulmonic) Valvuloplasty Catheters/Percutaneous Valvuloplasty Catheter OMZ
    Catheter, Ureteral, Gastro-Urology EYB
    Tape, Measuring, Rulers And Calipers FTY
    Stents, Drains And Dilators For The Biliary Ducts FGE
    Sound, Urethral, Metal Or Plastic FBX
    Fiber, Medical, Absorbent FRL
    Urinometer, Mechanical EXR
    Basin, Emesis FNY
    Surgical Instruments, G-U, Manual (And Accessories) KOA
    Device, Vein Stabilization LBJ
    Iliac Covered Stent, Arterial PRL
    Subcutaneous Implanted Apheresis Port PTD
    Needle, Conduction, Anesthetic (W/Wo Introducer) BSP
    Catheter, Ventricular, General & Plastic Surgery GBS
    Endoscopic Injection Needle, Gastroenterology-Urology FBK
    Stent, Iliac NIO
    Connector, Catheter GCD

    Proprietary Names

    Ultraverse 014 and 018 PTA Balloon Dilatation Catheters Bardex Lubri-Sil 3-Way Foley Cathet Bardex Lubri-Sil I.C. Foley Cathete BD Intelliport Sensor CO-SET+ Loc-Strap Bard Male External Catheter (OTC) Bard Infection Control Urinary Needleless Sample Port Control Fit Urine Collection Container - bag/urinary drainage unit Bard Deluxe Dispoz-A-Bag Drainage Bag (Leg Bag) Urinary Drainage Unit(urinary leg Urotrack Plus (Model 220) Bard Leg Bag Holder w/ accessories) Bed Bag SureStep Foley Tray System Add-A-Foley Catheter (for Canada) Bard Foley Catheterization Tray Uro-Prep Tray (for Canada) SureStep Foley Tray System Complete Care Add-A-Foley Catheter (for Canada) Bard Standard Latex Free Foley Tray without Catheter (for Canada) Bard Male External Latex Disposable Catheter Bardia Foley Catheter Insertion w/o Catheter with Lubricant in SureStep Intermittent Catheter Tray Bard® Universal Catheterization Tray Bardia Urethral Catheter Tray 5cc Balloon w/o Catheter w/o Catheter Foley Catheter Insertion Tray for 30cc Balloon w/o Catheter Bard Foley Catheterization Tray IMPRA Carboflo ePTFE Vascular Grafts True Flow Valvulplasty Perfusion Catheter PelviLace TO BioUrethral Support Sy Per-Q-Cath Catheter Introducer Bardex Lubri-Sil I.C. Foley Cath Lubri-Sil I.C. Foley Catheter (offered in strips and trays) Tracheal Suction Latex rubber Suction System Trach-Eze Closed Ventilation Bard Plastic Cath N Sleeve Bard Cath'N Sleeve with Solution Container Davol DeLee Tracheal Davol Tracheal Suction Catheter Bard Suction Catheter, DeLee Tracheal Bard Cath'N Sleeve Suction Kit Bard Catheter and Glove Suction Kit Davol Suction Catheter Bard Suction Catheter Bard Plastic Suction Catheter Davol Bronchial Aspirating Catheter Bard Tracheal Suction Tray Align Urethral Support System Economy 400 CWS with PVC Drain 100cc Silicone Evacuator ReliaVac 100 Closed Wound Suction 3-spring Y-connector BD Curve Ascites Shunt 42-4016, Introducer Kit 42-4012, Introducer Kit Bard Malleable Tip Catheter Stylet "J" Guidewires Bard Nitinol Guidewires Hyrdo-Glide Guidewire Bard Van Buren Curve Catheter Style NiCore Nitinol Guidewires Bard Mission Disposable Core Biopsy Instrument Bard Mission Disposable Core Biopsy Instrument Kit Bardex 9cm Latex Right Angle Drain Bard Heyman Nephrostomy Short Tip Bard Suprapubic Needle Adapter Bardex Heyman Nephrostomy Short Tip Councill Model Hollow Stylet Suprapubic Trocar and Cannula (Campbell Model) Concil Model Hollow Stylet Bard Specimen Container Hysterectomy "T" Drain Bard Suction Connector Catheter Repair Kit with Replacement Connector UltraScore Focused Force PTA Balloon Bard Cunnigham Incontinence Clamp Bard Penile Clamp Safe-T-Plus Safe-T-Centesis Dilation Catheter X-Force TM Nephrostomy Balloon BARD CARDIOTHORACIC ADAPTOR Max-Blade Coagulating Resector Bard Woven Phillips Follower PHILLIPS AND HEYMAN Bard Heyman Follower Straight Tip Huber Plus EndoBeam Holmium Laser Fibers Catheter Plug Bard Fecal Containment Device with Adhesive and Accessories Provena Midline Catheter SureStep Foley Tray System (for Canada) Bardex Lubricath Foley Catheter (for Canada) Preconnected Bardex Lubricath Catheter (for Canada) Bard Urine Meter Bladder Care Tray with Bardex Lubricath Foley Catheter (for Canada) SureStep Foley Tray System Bardex Lubricath Coude Foley Catheter (for Canada) Bard Urine Meter Foley Tray with Bardex Lubricath Foley Catheter (for Canada) Bard Foley Tray with Bard HydrophilicCoated Foley Catheter (for Canada) SureStep Foley Tray System Bard Lubricath Foley (for Canada) VAMP Venous/Arterial Blood Management Protection System PowerGlide Pro™ Midline Catheter PowerGlide Pro™ Midline Catheter with Cue™ Needle Tracking System StruXure Guidewire Alphacurve HemoSplit XK Rosenblatt Port Align Introducers Fast Track Tunneler Set PelviSoft Introducers InSnare Introducers Bard Latex Urethral Catheter (Tieman Model) Coude Tip Bardia Red Rubber Intermittent Catheters Syringe Assist Irrigation System Bard Syringe Assist Irrigation Syst PowerPort ClearVUE Slim Implantable Port MRI Port Anti-Reflux Filter Nasogastric Sump Tube with PreVent Pressure Monitoring Set Bardex I.C. Pediatric Foley Cath Whelan Moss T-Tubes (biliary catheter) Statlock Foley Catheter Stabilization Device VAMP Plus Venous/Arterial Blood Management Protection System Swan-Ganz Catheter MRI Hard Base Port UltraClip II MR Tissue Marker Pediatric & Infant Catheter Kit PowerPort with Groshong Catheter Fogarty Thru-Lumen Embolectomy Catheter MRI PowerPort DENVER PLEURAL EFFUSION SHUNT WITH EXTERNAL PUMP CHAMBER DENVER PLEURAL EFFUSION SHUNT Bard Mesh BARD Bard Mesh Pre-Shaped UltraCor Twirl Breast Tissue Marker Acumen IQ Fluid Meter Hohn Broviac Statlock Endotracheal Tube Bone marrow collection/transfusion kit Reliacath Nelation Catheter Titanium Port Bardex Lubri-Sil Foley Catheter Lubri-Sil Foley Catheter Nasogastric Sump Tube Dual Lumen, w Radiopaque Stripe Marks Groshong NXT Groshong NXT ClearVue Bard Extension Set Silastic Brand Foley Catheter Bard® Silastic® Foley Catheter DuaLok Breast Lesion Localization Wire Ghiatas Beaded Breast Localization Wire Eagle Inflation Device Bard Nylon Catheter Plug Bard Catheter Plug and Cap Foley Catheters Drains, Balloon Inflation Funnel on Bard "C" Clamp for Occluding Tubes, Hydrogel-Coated Urethral Catheter Bardex I.C. 4-Way Foley Catheter Pristine™ Long Term Hemodialysis Catheter Poly Per-Q-Cath Silicone Ureteral Coil Stent with Figure Four End Fluoro-4 Silicone Ureteral Coil Stent Fluoro-4 Silicone Ureteral Stent Urinary Diversion Stent Bard Silicone Ureteral Stenting BrachyStar Brachytherapy Needles brachytherapy seed implant needles BrachyStar Needles QuickLink Loader QuickLink Relay System SourceLink Loader Bard Davol ReliVac Stainless Steel Trocar Fogarty Graft Thrombectomy Catheter Fogarty Corkscrew Catheter Safe-T-Centesis™ Thora-Para Safe-T™ PLUS Option-VF Urinary Catheter with Adaptor Bard Magnum Reusable Core Biopsy Instrument Ultraverse 035 PTA Balloon Dilatation Catheter Fogarty Arterial Embolectomy Catheter PleurX Peritoneal Catheter System Tridyne PowerPICC Swan-Ganz Pacing-TD Catheter BARD URODYNAMIC CATHETER Groshong PICC Latex Foley Catheter Bardex I.C. Foley Catheter (offered in strips and trays) TruGuide Coaxial Biopsy Needles Bard TruGuide Disposable Coaxial Biopsy Needles PTFE Coated Foley Catheter w/ urine collection bag LubriSil Foley Catheter w/ collection bag PTFE Coated Foley Catheter w/ Leg Bag Hydrogel Coated Foley Catheter with Leg Bag Silicone Catheter Tray with Accessories including Leg Bag Hydrogel Coated Foley Catheter with Urine Collection Bag LubriSil Foley Catheter with Leg Bag Bard Foley Tray with Bardex All Silicone Foley Catheter (for Canada) PTFE Coated Foley Catheter w/ Urine Meter SureStep Foley Tray System Bardex All- Silicone Foley Catheter Tray (for Canada) Silicone Catheter Tray with accessories LubriSil Foley Catheter with urine collection bag Silicone Foley Catheter w/ urine collection bag PTFE Coated Foley Catheter w/ Bed Bag Hydrogel Coated Foley Catheter w/ urine collection container LubriSil Foley Catheter w/ urine collection container PTFE Coated Foley Catheter w/ urine collection container SureStep Foley Tray System Lubri-Sil Complete Care (for Canada) Bard Urine Meter Foley Tray With Bardex All-Silicone Foley Catheter (for Canada) SureStep Foley Tray System Bard Lubri-Sil Foley Catheter Tray (for Canada) SureStep Foley Tray System Bard All Silicone Foley Catheter Tray (for Canada) T-Handle Jamshidi Bone Marrow Biopsy and Aspiration Tray Rubber Utility Catheter Bard Red Rubber Utility Catheter Viking Diagnostic Electrode Tango Electrode Catheters Viking Soft Tip Electrode Catheters Presto Inflation Device X-Force Ureteral Dilation Balloon C Bard U-Balloon Dilation Catheter UROFORCE Balloon Bipolar Temporary Pacing Electrode Catheter Illinois Bone Marrow Aspiration Needle Illinois Bone Marrow Aspiration Tray T-Handle Illinois Bone Marrow Aspiration Tray Safe-T PLUS Tray T-Handle Illinois Bone Marrow Aspiration Needle PowerPort™ ClearVUE™ isp Implantable Ports PowerPort™ ClearVUE™ Slim Implantable Ports Hydro-Surg Extension tube Ajust Adjustable Single Incision Plastic Catheter Bard Silicone Elastomer-Coated Latex Foley Catheter Flexxicon Niagara Non-Sterile Vinyl Inlay Ureteral Stent with Hydroglid Inlay VersaFit Multilength Ureteral Inlay Uteral Stent Inlay VersaFit Ureteral Stent UltraClip II Tissue Marker Wing and UltraClip II Tissue Marker Coil Non-sterile Urine Collection Bag Bard Jejunal Tube Gastrointestinal Tube X-Force Nephrostomy Balloon Recon Support Catheter Vacuum Tubing Patient Tubing PureWick FEC Collection Canister PureWick Urine Collection Accessories Kit PureWick Urine Collection System PureWick MEC PureWick Male External Catheter PureWick Female External Catheter Nasopharyngeal Airway Solution Container Acumen IQ Sensor FloTrac Sensor VolumeView Sensor Sherlock GlidePath™ 10F Long Term Dialysis Catheter Sentrinex™ 3D Port Dressing Statlock Stabilization Device Accessory - Foam Strips Sensor Holder Wound Closure Tape Strips AllPoints™ Dressing Change Kit EnCor Breast Biopsy System – Accessories Jamshidi Bone Marrow Biopsy and Aspiration Tray T-Handle Jamshidi Bone Marrow Biopsy/Aspiration Needle Instrument, biopsy Jamshidi Bone Marrow Biopsy/Aspiration Needle Jamshidi Evolve Bone Marrow Biopsy and Aspiration Trays Safe-T PLUS Trays Jamshidi Evolve Bone Marrow Biopsy/Aspiration Needle T-Handle Jamshidi Bone Marrow Biopsy and Aspiration Trays Magic3 Go Intermittent Urinary Catheter Arctic Sun Temperature Management System BARDEX LUBRI-SIL LUBRICATH Conquest 40 PTA Dilatation Catheter Atlas Gold PTA Dilatation Catheter FloTrac Jr. Sensor UltraClip II US Tissue Marker Marker (Ribbon) UltraClip Dual Trigger Tissue I.C. Foley Catheter with Urine Collection Container I.C. Foley Catheter AquaFil Foley Catheter with Syringe Foley Catheter with AquaFil Magic3 Touchless Hydrophilic Intermittent Catheter System (for Canada) SureStep Foley Tray System Bardex IC Complete Care (for Canada) Lubri-Sil I.C. Complete Care Urine Meter Foley Tray (for Canada) SureStep Foley Tray System Bardex I.C. Complete Care Foley Catheter (for Canada) SureStep Foley Tray System Lubri-Sil IC Complete Care (for Canada) HemoSplit Bardex All-Silicone Pediatric Cath Bard Silver-Coated Endotracheal Tub True Dilatation Balloon Valvuloplasty Catheter Davol/Simon Dermatone Atlas PTA Balloon Dilatation Catheter Bard Dual Connector to 3.5 mm Plug 12' Monitor Cable Sensica UO System Bard CritiCore Venaflo II Bypass Graft Forceps SureStep Foley Tray System Bardex All Silicone Foley Catheter Tray (for Canada) Chiba Fine Needle Aspiration Device Avaulta Support System Avaulta Solo Support System Avaulta Plus Support System Magnum Core Biopsy Needles Bard Snare Retrieval Kit Coude Tip Temperature-Sensing Cath CritiCore (Coude) Foley Tray ALIGN AND ALIGN TO URETHRAL SUPPORT SYSTEMS Magic3 UroForce Balloon Dilation Catheter Fogarty Fortis Arterial Embolectomy Catheter Dorado PTA Balloon Catheter Bardex Pezzers Bardex Nephrostomy Bardex Angel Drain Bardex Malecot SorbaFix PermaFix HydroSil Clear Advantage ULtraflex Natural Aurora Transfix Wideband PopOn Spirit BD Trek™ Bone Marrow Biopsy System BD Trek™ Power Driver BD Trek™ Bone Lesion Biopsy System BD Trek™ Sterile Sleeve X-Port Inline X-Port duo Port Evacuator Ellik Evacuator Bard Ellik Bladder Evacuator Avaulta Plus Biosynthetic Support Avualta Solo Synthetic Support V-Max Roller Bar Electrodes Proxis™ Ureteral Access Sheath NBIH Temporary Pacing Electrode Catheter Balloon Bipolar Temporary Pacing Electrode Catheter, Right Heart Curve Semi-Floating Temporary Pacing Electrode Catheter GOETZ Temporary Pacing Electrode Catheter Ureteral Catheter Plastic Adapter SureLink Extension Cables Poly Per-Q-Cath PICC & Midline Vertus Foley Catheter SureStep Recovery Cone Removal System PTFE Felt Bard PTFE Felt Pledget Low Porosity PTFE Felt PTFE Felt (Thick) Bard PTFE Braided Tape Bard PTFE Thick Felt Pledget Campbell Surprapubic Trocar and Cannula Bard Intra-Abdominal Pressure Monitoring Device BARD INTRA-ABDOMINAL PR Bardex Lubri-Sil All-Silicone Lubricious Coated Foley Catheter 6F Bardex Lubri-Sil Catheter (strips and trays) SlimPort MRI Ultra Low Profile Port MRI Low Profile Port Soft Tissue Biopsy Drug Free Tray Jamshidi Menghini Soft Tissue Biopsy Needle/Syringe Economy Illinois Sternal/lliac Bone Marrow Aspiration Tray Safety Soft Tissue Biopsy Tray Economy Soft Tissue Biopsy Tray Illinois Bone Marrow Aspiration/Intraosseous Infusion Needle Soft Tissue Biopsy Tray Jamshidi Menghini Soft Tissue Biopsy Tray PelviSoft Acellular Collagen Matrix PELVISOFT HydroSil Go Intermittent Urinary Catheter GlidePath™ 13F Long Term Hemodialysis Catheter Niagara SlimCath Bardex All-Silicone Temperature- Sensing Foley Catheter Lubri-Sil I.C. Temperature-Sensing Foley Catheter (offered in strips and trays) Vaccess™ CT Low-Profile Power-Injectable Implantable Port Vaccess™ CT Power-Injectable Implantable Port PowerPort™ duo M.R.I.™ Implantable Port Kugel Bard Urethral Catheterization Tray Navarre Universal Drainage Catheter Navarre Opti-Drain Drainage Catheter Groshong Stabilization System SurePoint Tracker Stepping and All-Silicone Foley Catheter Lubri-Sil Foley Catheter (offered in strips and trays) Bardex Silicone Foley Catheter (offered in strips and trays) and Kit Model 2012 (Urotrack) Temperature Sensing Foley Catheter Urinary Drainage Container with Preattached Foley Catheter and Kit ArcticGel Pads Denali™ Vena Cava Filter System – Femoral and Jugular/Subclavian Delivery Kit Marquee™ Disposable Core Biopsy Instrument Marquee™ Disposable Core Biopsy Instrument Kit Edwards Oximetry Central Venous Catheter BD Oximetry Central Venous Catheter PleurX™ Touchless II Pre-Lubricated Urethral Kit VolumeView sensor Acumen IQ sensor UltraClip II Tissue Marker Titanium PowerPort isp Site-Rite Needle Guide Kits and Pro Composix Bardex Silicone Foley Catheter Positioning System Stylet Sherlock 3CG Tip Positioning System Sensor & Sherlock 3CG Tip Bard DigniShield Stool Management System ENFit Bard DigniShield Stool Management System Bard® DigniShield® Stool Management System Collection Bags Bile Bag Crosser iQ CTO Recanalization System Ultraverse RX PTA Balloon Dilatation Catheter ePTFE Cardiovascular Patch PowerLine PowerHohn Dynamic Tip Steerable Catheter Fogarty Spring Clips Clamp Inserts Handleless Clamps Advance Introducer and SecureLoc Safety Introducer SecureLoc Titanium Low Profile Port BardPort Titanium Ports X-Port Low Profile Port UDM-10 Urinary Drainage Monitoring Highlander 014 PTA Balloon Dilatation Catheter PelviLace BioUrethral Dilators Dualator Alyte Y-Mesh Graft Hickman Trifusion Distaflo Bypass Graft PeritX™ 2L Drainage Starter Pack PeritX™ 2L Drainage Kit PeritX™ 2L Drainage Starter Tote PeritX™ Peritoneal Catheter System PowerPICC SV Catheter PediaSat Oximetry Catheter Latex Foley Catheter with 30cc Preformed Balloon Bardia Foley Catheter Bard Lubricath Foley Catheter Intravascular Catheter Securement Device PowerGroshong PerFix SurePoint Stepping and Stabilization System Pezzer-Malecot Stylet Fogarty Occlusion Catheter GlidePath 7.5F Long-Term Hemodialysis Catheter Arctic Sun Model 2000 Temperature Management System Hydrogel/Silver-Coated Foley Cath & Foley Tray (I.C.) Urinary Catheter Interglide-Hydrophilic Intermittent Bard Sauvage Filamentous Fabric EnCor Ultra Breast Biopsy System and Accessories EnCor Enspire Breast Biopsy System and Accessories Bard Protective Barrier Film Bard HemoStar™ Long Term Hemodialysis Catheter GlidePath™ Long Term Hemodialysis Catheter HemoStar XK™ Long Term Hemodialysis Catheter Inlay Optima Multi-Length Ureteral Stent Inlay Optima Ureteral Stent Fogarty Biliary Balloon Probe Percutaneous Introducer Kit Swan-Ganz Bipolar Pacing Catheter (D97130F5) Swan-Ganz Pacing-TD Catheters Swan-Ganz Pacing Thermodilution TD Catheter (D200F7) Swan-Ganz Bipolar Pacing Catheter (D97120F5) Sherlock 3CG® Tip Positioning System (TPS) Stylet/T-Lock Assembly GlidePath Retro Long Term Hemodialysis Catheter Vida BAV Balloon Valvuloplasty Catheter Vida PTV Dilatation Catheter FST 14 Fr. Councill Tip Foley Urodynamic Monitor 4 Channel Monitor w/ Uroflow X-Port isp MRI Port Personal Catheter Polyurethane Ureteral Disposable Unisex Pre-Lubricated Urethral Catheter Kit, Rubber Urethral Catheter Bard Metal Sound, Adult Male Length With Prostatic Curve Bard McCrea Model Female Urethral Sound PowerLoc Titanium PowerPort Winged Infusion Set (WIS) Non-Safety Needle Swan-Ganz IQ catheter Rayon Balls Hydrogel-Coated Foley Catheter Bard Urine Meter with Bag Urine Collection Meter Bard Dual Lumen Ureteral Catheter Emesis Basin BARDIC CYSTOSCOPIC IRRIGATION UNIT Vein Pick Repair Kit Elyra Thulium Laser Fibers Elyra Thulium Fiber Laser System and Accessories LifeStream Balloon Expandable Vascular Covered Stent Bard Max-Core Disposable Core Biopsy Instrument Bard Monopty Disposable Core Biopsy Instrument Kit Bard Monopty Disposable Core Biopsy Instrument Bard Marquee Disposable Core Biopsy Instrument Kit Bard Marquee Disposable Core Biopsy Instrument CS Assist Diagnostic Catheter Radia XT Steerable Diagnostic Catheter EP XT Steerable Catheter Dynamic XT Steerable Catheter PowerPort™ isp Implantable Port PowerPort™ Slim Implantable Port PowerPort™ M.R.I. ™ Implantable Port PowerPort™ M.R.I.™ isp Implantable Port Fogarty Venous Thrombectomy Catheter Latex Foley Catheter & Drains Bardex Councill Model Foley Catheter Percutaneous Nephrostomy Bardex Nephrostomy Short Tip Councill Model Foley Catheter with Heyman Stylet Lubricath Foley Catheter (offered in strips and trays) Bard Urologist Tray Bard Urologist Tray (for Canada) Davol Silicone Sheath Sump Drain Per-Q-Cath MidLine Bard Tigertail Ureteral Catheter Progel Bard AquaGuide Ureteral Access Shea AquaGuide Ureteral Access AQUAGUIDE-BARD AQUAGUIDE Seeker Crossing Support Catheter Tegress Transurethral Stainless Ste Tegress Transurethral Flexible Impl Vacora Vacuum Assisted Biopsy Sys Funnel Stomach/Intestinal Tube with Bulb Bardex Double Pigtail Stent Bard Lubricious-Coated Ureteral Stent with Suture Coil Stent Bardex Double Pigtail Ureteral Stent with Suture Bard Fluoro-4 Silicone Ureteral Stent Ureteral Coil Stent with Figure Four End Connector Tubing Universal PVC Y-Connector Bard Davol ReliaVac PVC Drain Conquest PTA Dilatation Catheter UltraClip Dual Trigger Breast Tissue Marker (Wing and Coil) PowerHickman

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    Sterilize Medical Device for Another Party (Contract Sterilizer) Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device Complaint File Establishment per 21 CFR 820.198 Repack or Relabel Medical Device Manufacture Medical Device for Another Party (Contract Manufacturer)