FDA Registration Active 🇦🇺 Australia

Merit Medical Australia Pty Ltd.

Reg #: 3033589330 · FEI: 3033589330 · Expires 2026
Products
129
Proprietary Names
405
Establishment Types
1
Classifications
129

Registration Details

Registration Name
Merit Medical Australia Pty Ltd.
Registration Number
3033589330
FEI Number
3033589330
Status
Active
Expiry Year
2026
Initial Importer
No
Address
53 Canterbury Road
City
Braiside Victoria
Country
AU

Regulatory Submissions

510(k) Number
K170933
PMA Number
P240023

Owner / Operator

Firm Name
Merit Medical Systems, Inc.
Operator Number
1721504
Address
1600 West Merit Parkway, --
City
South Jordan
State
UT
Postal Code
84095
Country
US

US Agent

Business Name
MERIT MEDICAL SYSTEMS, INC.
Contact Name
John Knorpp
Address
1600 West Merit Parkway, --
City
South Jordan
State
UT
ZIP
84095
Country
US
Phone
801 2084389

Products

Device Name Product Code
Wire, Guide, Catheter DQX
Catheter, Percutaneous DQY
Instrument, Biopsy KNW
Cement, Bone, Vertebroplasty NDN
Dispenser, Cement KIH
Device, Measuring, For Panendoscope FDY
Catheter, Intravascular, Diagnostic DQO
Intravenous Extension Tubing Set OJA
Wire, Guide, Catheter, Exempt PTL
Introducer, Catheter DYB
Bedding, Disposable, Medical KME
Prosthesis, Tracheal, Expandable JCT
Hemostatic Wound Dressing Without Thrombin Or Other Biologics QSY
Cap, Device Disinfectant QBP
Dilator, Vessel, For Percutaneous Catheterization DRE
Bit, Drill HTW
Unit, Filter, Membrane JRL
Dilator, Esophageal KNQ
Device, Vascular, For Promoting Embolization KRD
Catheter, Continuous Flush KRA
Accessories, Catheter KGZ
Cart, Emergency, Cardiopulmonary (Excluding Equipment) BZN
Bone Cement LOD
Needle, Aspiration And Injection, Disposable GAA
Transducer, Blood-Pressure, Extravascular DRS
Mechanical Thrombolysis Catheter QEY
Bag, Bile Collecting EXF
Catheter, Peritoneal Dialysis, Single Use FKO
Apparatus, Suction, Patient Care DWM
System, Peritoneal, Automatic Delivery FKX
Marker, Radiographic, Implantable NEU
Syringe, Piston FMF
Biopsy Needle FCG
Device, Biopsy, Endomyocardial DWZ
Endoscope Introducer Kit NWU
Catheter, Irrigation GBX
Catheter, Hemodialysis, Implanted MSD
Bulb, Inflation, For Endoscope FCY
Catheter, Peritoneal, Long-Term Indwelling FJS
Arthroscope HRX
Trocar DRC
Support, Patient Position CCX
Clamp, Vascular DXC
Stopcock, I.V. Set FMG
Instrument, Manual, Surgical, General Use MDM
Device, Percutaneous Retrieval MMX
Angiography/Angioplasty Kit OEQ
Guide, Surgical, Instrument FZX
Actuator, Syringe, Injector Type DQF
Set, Administration, Intravascular FPA
Universal Drainage Tray PPD
Probe, Thermodilution KRB
Aspiration Thrombectomy Catheter QEZ
Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days FOZ
Reverse Central Venous Recanalization System QJH
Single Use Instrument Tray OJV
Injector And Syringe, Angiographic DXT
Needle, Biopsy, Cardiovascular DWO
System, Applicator, Radionuclide, Remote-Controlled JAQ
Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass DTL
Unit, Cryosurgical, Accessories GEH
Prosthesis, Vascular Graft, Of 6mm And Greater Diameter DSY
Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days LJS
Minor Surgical Procedures Tray PYB
Stents, Drains And Dilators For The Biliary Ducts FGE
Mixer, Cement, For Clinical Use JDZ
Tourniquet, Nonpneumatic GAX
Syringe, Balloon Inflation MAV
System, Measurement, Blood-Pressure, Non-Invasive DXN
Peritoneal, Drainage Catheter For Refractory Ascites, Long-Term Indwelling PNG
Infusor, Pressure, For I.V. Bags KZD
Dialysis Administration Kit PEV
Paracentesis Tray PYC
Device, Neurovascular Embolization HCG
Tubing, Fluid Delivery FPK
Syringe, Balloon Inflation, Exempt PTM
Computer, Blood-Pressure DSK
Electrosurgical, Cutting & Coagulation & Accessories GEI
Cannula, Surgical, General & Plastic Surgery GEA
Endoscopic Guidewire, Gastroenterology-Urology OCY
Tourniquet, Pneumatic KCY
System, Endovascular Graft, Arteriovenous (Av) Dialysis Access Circuit Stenosis Treatment PFV
Orthopedic Manual Surgical Instrument LXH
Thoracentesis Tray PXI
Guide, Needle, Surgical GDF
Prosthesis, Esophageal ESW
Catheter And Tip, Suction JOL
Stylet, Surgical, General & Plastic Surgery GAH
Dilator, Catheter GCC
Peripheral Catheter Insertion Kit OWL
Syringe, Irrigating (Non Dental) KYZ
Computer, Diagnostic, Pre-Programmed, Single-Function DXG
Endoscopic Access Overtube, Gastroenterology-Urology FED
Bronchoscope Accessory KTI
Absorbable Lung Biopsy Plug OMT
Dressing, Compression MHW
Injector, Vertebroplasty (Does Not Contain Cement) OAR
Tunneled Catheter Remover ODY
Bottle, Collection, Vacuum KDQ
Vacuum Syringe PUR
Endoscopic Irrigation/Suction System OCX
Device, Intravascular Catheter Securement KMK
Non-Bronchoscopic Bronchoalveolar Lavage Catheter OYI
Stent, Ureteral FAD
Kit, Surgical Instrument, Disposable KDD
Bandage, Elastic FQM
Electrode, Pacemaker, Temporary LDF
Catheter, Peritoneal GBW
Cardiovascular Catheter Sheath Introducer Kit OEX
Instruments, Surgical, Cardiovascular DWS
Unit, Electrosurgical, Endoscopic (With Or Without Accessories) KNS
Catheter, Steerable DRA
Transducer, Pressure, Catheter Tip DXO
Cystoscope And Accessories, Flexible/Rigid FAJ
Endoscopic Suture/Plication System, Gastroesophageal Reflux Disease (Gerd) ODE
Agents, Embolic, For Treatment Of Benign Prostatic Hyperplasia NOY
Tamp HXG
Cardiovascular Procedure Kit OEZ
Blade, Scalpel GES
Probe, Radiofrequency Lesion GXI
Label Or Tag, Sterile LYV
Pulse-Generator, Pacemaker, External DTE
Needle, Catheter GCB
Fluid Drainage Tray PXU
Retention Device, Suture KGS
Instrument, Surgical, Disposable KDC
Tubes, Vials, Systems, Serum Separators, Blood Collection JKA
Tape And Bandage, Adhesive KGX
Table And Attachments, Operating-Room BWN

Proprietary Names

Merit Hydrophilic Guide Wire Ventrax Delivery System TruCut 18Ga MultiPlex II Controller Activation Element, ERx bone cement Aerosizer Impress UAC Catheter K08 Fluid Management Kit K04 - Tubing Kit Pinvise Torque Device SeaDragon Torque Device HeartSpan Steerable Sheath Introducer DriPAD Super Absorbent Pad InQwire Amplatz Super Stiff Guide Wire AEROmini Tracheobronchial Stent System STATSEAL WOUNDSEAL DualCap Solo DualCap DualCap Duo DualCap IV Pole Strips Dark Blue Cap for Male Luers Prelude Sheath Introducer PreludeEASE Hydrophilic Sheath Introducer, 4F-6F Merit PAK SPINR High-Performance Guidewire Catheter VertecoR Bone Drill, 3 Osseoflex Straight Hand Drill Preston™ Transpedicular Drill Preston™ Hard Bone Introducer Preston™ Long Drill MiniStop Filter Closed Waste Basin Merit Pursue Microcatheter Elation Fixed Wire Balloon Elation5 Wireguided Balloon Elation5 Fixed Wire Balloon Torpedo Gelatin Foam Maestro Microcatheter Valve Adapter Prelude SNAP 165 Valved Splittable Sheath Introducer SCOUT Console and Accessory Cart Osseoflex SB Steerable Balloon (10Ga) Dash 9F Hydrophilic Sheath Introducer ShortStop Grandstand Temporary Sharps Holder ShortStop Advantage Temporary Sharps Holder MiniStop Plus Closed Waste Basin ShortStop Temporary Sharps Holder BackStop Plus Closed Waste Basin Kensington Guide Wire Bone Biopsy System Madison™ Perforating Bone Biopsy System with Drill Westbrook™ Bone Biopsy System Madison Mini™ Bone Biopsy System Bedford™ Guided Hard Bone Biopsy System Huntington Guided, Perforating Bone Biospy System with Drill Pressure Tubing Squirt Fluid Delivery System Merit Drainage Depot Peritoneal Dialysis Catheter Connector Aspira Peritoneal Drainage System Stylette (rod obturator) SCOUT Bx Delivery System Medallion Syringe K01 Kit (MSS) Spectranetics K02 Syringe Kit (multiple K01)) Temno Original Temno ACT Novatome Endomyocardial Biopsy Forceps K20 Endoscopic Kit BRC-BAL-INT-FL/A K20T - Endoscopic Kit ReSolve Non-Locking Drainage Catheter ReSolve Locking Drainage Catheter One-Step Centesis Catheter FastBreak Connector Cen-Step Centesis Catheter Duramax ClariVein IC Infusion Catheter EvenMore Chronic Hemodialysis Catheter Merit Syringe Insufflation Set ARC Catheter Osseoflex SB Steerable Balloon (8ga) Merit CentrosFLO Long-Term Hemodialysis Catheter Merit Centros Long-Term Hemodialysis Catehter Advance Angiographic Needle Majestik Angiographic Needle Transseptal Needle,HeartSpan Transseptal Needle&Stylet Set,TSX Transseptal Needle,Transseptal Needle&Stylet Set;et al. PreludeEASE Hydrophilic Sheath Introducer, 7F Temno Evolution Critiflo Disposable Diaphragm Dome Rad Rest Flex-Neck Infant Catheter PreludeSYNC DISTAL Radial Compression Device PreludeSYNC EVO Radial Compression Device Connecta PE Lines StabiliT Introducer and Delivery Instruments Maxxwire EN Snare Endovascular Snare System VACLOK Syringe K02 Syringe Kit (multiple K01) TruCut 14Ga S-MAK XL K12 Procedure Kit K19 Combination Packs K05 Inflation Kit K23C Vein Accessory Kit K22C Vein Tray K12T - Procedure Kit K05T - Inflation Kit 10Fore Hemostasis Valve Kit K02-00873A, K02-01105A, K02-01481A Merit 20 mL Syringe (COP) K01 Syringe Kit (1mL & 20mL COP) Fountain ValveTip Infusion Catheter BowTie Guide Wire Insertion Device Spectraject Control Syringe Merit Administration Set CT Transfer Set Impress and Impress Legato Hydrophilic Angiographic Catheter Aero DV Tracheobronchial Stent System Hydrophilic Guidewire K10 Waste Management Kit K10T - Waste Management Kit Roadster Guide Sheath ROSE Critikit Plus In-Line Room/ Ice Injectate ASAPLP Embolectomy Catheter SCOUT MD Console SCOUT MD Delivery System SCOUT MD Guides SCOUT MD Single-Use Handpieces Prelude Short Sheath Introducer Careflow Central Venous Catheter Surfacer Inside-Out Access Catheter System SafeSafeSheath, ClassicSheath, Input SSV , Split Sheath Introducer Kit With Valve; et al. Merit Convenience Kits StabiliT ER2 Bone Cement and Saturate Mixing System StabiliT MX Fracture Kits StabiliT VP Vertebrosplasty Kit StabiliT VP Fracture Kits StabiliT MX Fracture Kits with PowerCURVE StabiliT Bone Cement and Saturate Mixing System Prelude Wave Hydrophilic Sheath Introducer Intellisystem Inflation Device Fluid Dispensing Syringe Prelude Prestige Splittable Sheath Introducer SAVI Applicator Kit Merit 1mL Syringe (COP) Flex-Neck Extender/Repair Kit Corvocet Biopsy System TRAM-P TRAM C2 Cryoballoon Ablation System Secalon T Catheter Merit HeRO Graft K13 Label Kit ReSolve Biliary Locking Drainage Catheter Temno Elite Biopsy Systems SwiftNINJA Microcatheter HeartSpan Steerable Introducer Sheath Prelude SNAP Splittable Sheath Introducer ER2 Saturate Mixing System HeartSpan Fixed Curve Braided Transseptal Sheath, Braided Guiding Introducer, EZ Cross Introducer Kit; et al. CardiaGuide Fixed Curve Braided Transseptal Sheath Finale Radial Compression System RADstat Radial Artery Compression Device Vessel Dilator DiamondTOUCH Inflation Device and Fluid Dispensing Syringe DTX Disposable Temperature Probe DTX/DTX Plus Kit and Accessories DTX Plus Disposable Pressure Transducer SwiftNINJA Steerable Microcatheter Aspira Pleural Drainage System Pressure Infusor Bags (PIB) K14 Dialysis Kit Aero Tracheo Stent and Delivery System Concierge Guiding Catheter PreludeSYNC EZ Radial Compression Device SCOUT Single-Use Handpiece, SCOUT Surgical Guides SCOUT Reflector and Delivery Systems SCOUT Surgical Console and SCOUT Check Console Osseoflex SB Straight Balloon (8ga) Merit MAK (Mini Access Kit) Merit S-MAK (Stiffened Mini Access Kit) Safety Paracentesis Tray (SPPT) Drainage Tubing EmboGold Microspheres Corvocet Coaxial Introducer Excite Contrast Injection Line Merit Pressure Monitoring Tubing Merit High Pressure Tubing Impress with Legato Hydrophilic Coating Miser Contrast Management System basixCompak Analog Inflation Syringe basixTOUCH BIG60 basixTOUCH40 Inflation Syringe BIG60 ALPHA Inflation Devie basixSKY Inflation Device Safedraw Blood Sampling System SpineSTAR Ablation Instruments STAR Tumor Ablation Kit with PowerCURVE STAR Tumor Ablation Kit and Accessories MetaSTAR RF Generator Performa Diagnostic Intravascular Catheter Preston™ Transpedicular Introducer Preston™ Hard Bone Access Needle with Drill Preston Bone Filler InQwire Diagnostic (Support) Non-Vascular Guide Wire Prelude IDeal Hydrophilic Sheath Introducer Tubing, Fluid Delivery Safeguard Pressure Assisted Device (12cm) Guidewire with Palladium Tip Micro Ace Gold Advanced Micro Access System Faller Trocar Wrapsody Cell-Impermeable Endoprosthesis Prelude Sheath Half Size (ACT) Meritrans ECO Reusable Pressure Transducer and Meritrans ECO Disposable Domes Straightline Osteotome, VerteCOR Midline Osteotome PowerCURVE Navigating Osteotome Micro Plug Set QuadraSphere Q2 Microspheres QuadraSphere Microspheres Thoracentesis Tray (TAPS) Universal Coaxial Needles HeRO Graft Alimaxx E Exacta Percutaneous Sheath Introducer InQwire Guidewires Repositional Chest Tube RTT14038MB Merit Disposal Depot Osseoflex SN Osseoflex SN+ Needle Osseoflex SN Needle Osseoflex Access Kit ReSolve Dilators Non-vascular tissue dilators DuraFlow 2 Hemodialysis Catheter K16 Microcatheter Kit RXP (Rapid Exchange Flushing Syringe) Bath Probe Catheter Connection Cables and Cardia Computer Injectate Sensor Cable Sidecar External Working Channel (FG-1011) Elation Pulmonary Balloon InQwire Merit InQwire® Amplatz Super Stiff Guide Wire FlowGuard Micro Ace Advanced Micro Access System Embedding Tool ReSolve ConvertX Biliary Stent System Merit Safety Needle Coronary Control Syringe K06 Syringe Kit (single CSS) K07 Syringe Kit (multiple K06) BioSentry Tract Sealant System SafeGuard Focus Compression Device SafeGuard Focus Cool Device Resilience Fully Covered Esophageal Stent System X-Change Cement Dispensing Syringe Hydraulic Assembly Osseon Bone Filler Device (BFD) StabiliT Cement Delivery Syringe Hydraulic-Master Syringe Assembly Purge Assist Master Syringe Assembly DiamondTOUCH Syringe OuTake Catheter Extractor OneSnare Endovascular Snare System CentrosFLO Long-Term Hemodialysis Catheter Centros Long-Term Hemodialysis Catheter One-Vac Evacuated Drainage Bottle VacLok AT Syringe C2 Cryoballoon Endogrip Elation Pulmonary Balloon 4mm Osseoflex SB Straight Balloon (10ga) Revolution Catheter Securement Dev. Safeguard Radial Compression Device Brochoalveloar Lavage (BAL) Custom Convenience Kit ReSolve ConvertX Nephroureteral Stent System Sterilized Convenience Kits S-MAK Meritrans Disposable Transducer Acutiy Universal Cutter Mighty Wire H20 Guidewire Rotating Adaptor Stopcock One Port Manifold Hemostasis Valve Adapter SafeSheath Sealing Adapter Merit Manifold DoublePlay Hemostasis Valve MYSHELL Hemostatic Valve FLO30 Honor hemostasis valve Passage Hemostasis Valve FLO40XR Merit Marquis Flow Switch Merit Marquis Stopcock Prelude Choice Hemostasis Valve Adapter PhD Hemostasis Valves & PhD Hemostasis Valves with Sidearm Tubing Access-9 H20 Torque Device AccessPLUS MBA Check Valve NeoVasc FLO50 10Fore Hemostasis Valve Low Profile Companion Sheath Fountain 4F Catheter & Occluding GW SafeGuard Focus Compression Device (Adhesive Free) SafeGuard Focus Cool Device (Adhesive Free) Solo Pace Fusion System (SOLOFUSE1) Percutaneous Peritoneal Dialysis Catheter Implantation Systems (VP-511, VP-511M) Laparoscopic Peritoneal Dialysis Catheter Implantation Systems (VP-411) Peritoneoscopic or Laparoscopic Peritoneal Dialysis Catheter Implantation Systems (VP-210, VP-211) EndoMAXX Critiflo Dome Critiflo Siege Vascular Plug K18 Sheath Introducer Kit (Ease) K15 Sheath Introducer Kit K21 Sheath Introducer Kit (IDeal) Smart Tip Control Syringe SCOUT MD Single-use Handpieces PinVise Torque Device Fountain Catheter/Occluding Guide Wire Softouch Diag. Intra Cath. w/Vessel Vessel Sizing Catheter (VSC) Bulldog Lead Extender Contamination Sleeve, Cutter, Worley Slitter, Transavalvular Insertion Tool (TVI) One-Tie Compression Coil Lead Clippers Worley Impress Angiographic Catheter Quick Silver HeartLight Deflectable Sheath Physiological Reusable Pressure Transducer Integral Injectate Temperature Probe Catheter Connection Cable Disposable In Line Sensor Housing Hydrophilic Prelude SNAP Splittable Sheath Introducer Adjustable Biopsy Port Seal BPS-A Achieve Pink Achieve EsophyX Z+ Device Embosphere Microspheres Emboshpere PRO Arcadia Balloon Catheter KYPHON KyphoFlex Balloon Catheter Kit KYPHON KyphoFlex Balloon Catheter Arcadia Balloon Catheter Kit K11 Pressure Monitoring Kit K17 Interventional Kit K09 Manifold Kit K17T - Interventional Kit K09T - Manifold Kit Futura Safety Scalpel ViaVerte RF Generator ViaVerte Steerable RF Ablation Kit Safeguard Pressure Assisted Dressing (24cm) SAVI Prep Device SAVI Spacer Monarch Syringe Fluid Dispense System Prelude Plastic Jacketed Guide Wire PAL (Pen and Labels) Family True Form Reshapable Guide Wire Ostial Pro Stent Positioning System BioFlo Duramax ExxTended Catheter Go2Wire Guide Wire Osseoflex CD-H Hydraulic Cement Delivery System Elation Wireguided Balloon Solo Pace Control ASAP Aspiration Catheter ASAPLP Aspiration Catheter K01 Syringe Kit (1mL Polypropylene) 1 mL syringe(Polypropylene) Introducer Needle WithTrocar Stylet MAK-NV Non-Vascular Merit Triboglide Syringe Pericardiocentesis Catheter Kit Slip-Not Perchik Button Assembly Cuff Implantor SafT Needle Direct Blood Transfer Flex-Neck Catheter StayFix Fixation Device SureCross Support Catheter ASAP Catheter SafeSheath CSG Introducer Sheath Kit , Worley Advanced CSG , Worley Advanced LVI Lateral Vein Introducers, et al. ProGuide Long Term Hemodialysis Catheter 5.5 F Worley Advanced LVI Lateral Vein Introducer Monarch Compak Inflation Syringe Blue Diamond Inflation Syringe Rad Trac Rad Board Xtra Rad Board Rad Board 2 Reusable Arm Board One Snare Endovascular Snare System ONE1501 Fountain Infusion Catheter w/ Occluding Guide Wire Fountain Infusion System

Establishment Types

Export Device to the United States But Perform No Other Operation on Device