AccessGUDID - DEVICE: HeRO® Graft Accessory Component Kit (00877234000089)

GUDID

Device Identifier (DI) Information

Brand Name: HeRO® Graft Accessory Component Kit
Version or Model: HERO 1003
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: HERO 1003
Company Name: Artivion, Inc.

Primary DI Number: 00877234000089
Issuing Agency: GS1
Commercial Distribution End Date: June 22, 2016
Device Count: 1
Labeler D-U-N-S® Number*: 119253177 *Terms of Use

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

What MRI safety information does the labeling contain?	MR Conditional
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	Yes
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	Yes
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
MSD	Catheter, Hemodialysis, Implanted
LJS	Catheter,Intravascular,Therapeutic,Long-Term Greater Than 30 Days
DSY	Prosthesis, Vascular Graft, Of 6mm And Greater Diameter

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: Keep Dry and Out of Direct Sunlight
Storage Environment Temperature: between 15 and 30 Degrees Celsius

Clinically Relevant Size

[?]

Size Type 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

Device Record Status

Public Device Record Key: 0348aa70-454f-4096-b241-19dac357573f
Public Version Date: February 19, 2024
Public Version Number: 4
DI Record Publish Date: September 23, 2015