HeRO® Graft Accessory Component Kit

Basic Information

• Brand Name: HeRO® Graft Accessory Component Kit
• Primary DI: 00877234000089
• Version / Model: HERO 1003
• Catalog Number: HERO 1003
• Company Name: Artivion, Inc.
• Labeler DUNS: 119253177
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-09-23
• Public Version: 4
• Public Version Date: 2024-02-19
• Public Version Status: Update
• Public Device Record Key: 0348aa70-454f-4096-b241-19dac357573f
• Distribution End Date: 2016-06-22

Device Description

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.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: MR Conditional
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
MSD	Catheter, Hemodialysis, Implanted	Gastroenterology, Urology	876.5540	2
LJS	Catheter,Intravascular,Therapeutic,Long-Term Greater Than 30 Days	General Hospital	880.5970	2
DSY	Prosthesis, Vascular Graft, Of 6mm And Greater Diameter	Cardiovascular	870.3450	2

GMDN Terms

Code	Name	Definition	Implantable	Status
13586	Arteriovenous shunt	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.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00877234000089	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			16 French Dilator, Outer Diameter: 16 French
Device Size Text, specify			10 French Stylet, Outer Diameter: 10 French
Device Size Text, specify			10 French Stylet, Length: 47 Centimeters
Device Size Text, specify			20 F Sheath Introducer & Dilator, Sheath Length: 5.8 Inches
Device Size Text, specify			20 F Sheath Introducer & Dilator, Sheath Inner Diameter: 20 French
Device Size Text, specify			20 F Sheath Introducer & Dilator, Dilator Length: 7.9 Inches
Device Size Text, specify			20 F Sheath Introducer & Dilator, Dilator Inner Diameter: 0.041 Inches
Device Size Text, specify			20 F Short Sheath Introducer & Dilator, Sheath Length: 3.13 Inches
Device Size Text, specify			20 F Short Sheath Introducer & Dilator, Sheath Diameter: 20 French
Device Size Text, specify			20 F Short Sheath Introducer & Dilator, Dilator Length: 4.75 Inches
Device Size Text, specify			20 F Short Sheath Introducer & Dilator, Dilator Inner Diameter: 0.041 Inches
Device Size Text, specify			12 French Dilator, Length: 7.9 Inches
Device Size Text, specify			12 French Dilator, Outer Diameter: 12 French
Device Size Text, specify			16 French Dilator, Length: 7.9 Inches

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Keep Dry and Out of Direct Sunlight
• Type: Storage Environment Temperature
• Temperature Range: 15 – 30 Degrees Celsius