The HeRO (Hemodialysis Reliable Outflow) Graft is a long-term access solution for access-challenged and catheter-dependent patients. HeRO Graft is a fully subcutaneous surgical implant. It provides arterial venous (AV) access with continuous outflow into the central venous system. HeRO Graft traverses central venous stenosis allowing for long-term hemodialysis access. HeRO Graft consists of two primary components: • A proprietary Venous Outflow Component • A proprietary Arterial Graft Component The HeRO Graft Accessory Components provides instruments and accessories (such as, peel away sheaths and dilators, stylet, disposable clamp, hemostasis plug and hemostatic Y-valve with stopcock) that may aid in the placement of the HeRO Graft.


Product Overview

The HeRO (Hemodialysis Reliable Outflow) Graft is a long
HeRO® Graft Accessory Component Kit - HERO 1003


Device Description

An implanted device designed to provide a passage for blood to flow between an artery typically located in an arm, and a peripheral vein, central vein or right atrium, creating a graft fistula that provides blood access for external procedures, especially haemodialysis. It is a synthetic vascular graft/graft assembly with a thin wall and appropriate size (commonly 6 mm diameter) and configuration to facilitate vessel puncturing. It is typically used when it is not possible or convenient to create a direct arteriovenous fistula or for patients who have exhausted peripheral venous access. Disposable devices associated with implantation may be included.


Environmental Conditions

  • Special Storage Condition, Specify
    • Keep Dry and Out of Direct Sunlight
  • Storage Environment Temperature - Degrees Celsius
    • 30.00
    • 15.00

  • Device Sizes

  • 16 French Dilator, Outer Diameter: 16 French
  • 10 French Stylet, Outer Diameter: 10 French
  • 10 French Stylet, Length: 47 Centimeters
  • 20 F Sheath Introducer & Dilator, Sheath Length: 5.8 Inches
  • 20 F Sheath Introducer & Dilator, Sheath Inner Diameter: 20 French
  • 20 F Sheath Introducer & Dilator, Dilator Length: 7.9 Inches
  • 20 F Sheath Introducer & Dilator, Dilator Inner Diameter: 0.041 Inches
  • 20 F Short Sheath Introducer & Dilator, Sheath Length: 3.13 Inches
  • 20 F Short Sheath Introducer & Dilator, Sheath Diameter: 20 French
  • 20 F Short Sheath Introducer & Dilator, Dilator Length: 4.75 Inches
  • 20 F Short Sheath Introducer & Dilator, Dilator Inner Diameter: 0.041 Inches
  • 12 French Dilator, Length: 7.9 Inches
  • 12 French Dilator, Outer Diameter: 12 French
  • 16 French Dilator, Length: 7.9 Inches
    • 16 French Dilator, Outer Diameter: 16 French
    • 10 French Stylet, Outer Diameter: 10 French
    • 10 French Stylet, Length: 47 Centimeters
    • 20 F Sheath Introducer & Dilator, Sheath Length: 5.8 Inches
    • 20 F Sheath Introducer & Dilator, Sheath Inner Diameter: 20 French
    • 20 F Sheath Introducer & Dilator, Dilator Length: 7.9 Inches
    • 20 F Sheath Introducer & Dilator, Dilator Inner Diameter: 0.041 Inches
    • 20 F Short Sheath Introducer & Dilator, Sheath Length: 3.13 Inches
    • 20 F Short Sheath Introducer & Dilator, Sheath Diameter: 20 French
    • 20 F Short Sheath Introducer & Dilator, Dilator Length: 4.75 Inches
    • 20 F Short Sheath Introducer & Dilator, Dilator Inner Diameter: 0.041 Inches
    • 12 French Dilator, Length: 7.9 Inches
    • 12 French Dilator, Outer Diameter: 12 French
    • 16 French Dilator, Length: 7.9 Inches


    Device Sterilization

    Device Sterile: True

    Sterilization Prior To Use: False

    Sterilization Methods: No Data Available


    Product Codes

    Code: MSD

    Device Name: Catheter, Hemodialysis, Implanted

    Device Class: 2

    Physical State: N/A

    Definition: N/A

    Submission Type ID: 1

    Review Panel: GU

    Review Code: N/A

    Technical Method: N

    Gmp Exempt Flag: N/A

    Life Sustain Support Flag: Y

    Unclassified Reason: N/A

    Implant Flag: Y

    Target Area: N/A

    Regulation Number: 876.5540

    Third Party Flag: N

    Medical Specialty: GU


    Code: LJS

    Device Name: Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days

    Device Class: 2

    Physical State: N/A

    Definition: N/A

    Submission Type ID: 1

    Review Panel: HO

    Review Code: N/A

    Technical Method: N

    Gmp Exempt Flag: N/A

    Life Sustain Support Flag: N

    Unclassified Reason: N/A

    Implant Flag: Y

    Target Area: N/A

    Regulation Number: 880.5970

    Third Party Flag: N

    Medical Specialty: HO


    Code: DSY

    Device Name: Prosthesis, Vascular Graft, Of 6mm And Greater Diameter

    Device Class: 2

    Physical State: N/A

    Definition: N/A

    Submission Type ID: 1

    Review Panel: CV

    Review Code: N/A

    Technical Method: N

    Gmp Exempt Flag: N/A

    Life Sustain Support Flag: N

    Unclassified Reason: N/A

    Implant Flag: Y

    Target Area: N/A

    Regulation Number: 870.3450

    Third Party Flag: N

    Medical Specialty: CV


    Device Identifiers

    Device Id: 00877234000089

    Device Type: Primary

    DeviceId Issuing Agency: GS1

    Contains DI Number: N/A

    Package Quantity: N/A

    Package Discontinue Date: N/A

    Package Status: N/A

    Package Type: N/A


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