Home GUDID 00877234000072
HeRO® Graft Arterial Graft Component
Primary DI 00877234000072
Brand HeRO® Graft Arterial Graft Component
Company Artivion, Inc.
Model HERO 1002
Catalog number HERO 1002
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 ComponentThe HeRO Graft Arterial Graft Component has a 6mm ID, 7.4mm OD, and is 53cm long, inclusive of the connector. It consists of an ePTFE hemodialysis graft with PTFE beading to provide kink resistance near the titanium connector. The titanium connector attaches the Arterial Graft Component to the HeRO Graft Venous Outflow Component. The HeRO Graft Arterial Graft Component is cannulated using standard technique according to KDOQI guidelines.
Published 2015-09-23
Public version status Update
Distribution status Not in Commercial Distribution
MRI safety MR Conditional
Rx true
Sterile true
Single use true
Product Codes# Code, Name table Code Name DSY Prosthesis, Vascular Graft, Of 6mm And Greater Diameter LJS Catheter,Intravascular,Therapeutic,Long-Term Greater Than 30 Days MSD Catheter, Hemodialysis, Implanted
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class DSY Prosthesis, Vascular Graft, Of 6mm And Greater Diameter Cardiovascular 2 LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days General Hospital 2 MSD Catheter, Hemodialysis, Implanted Gastroenterology, Urology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00877234000072 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00877234000072 00877234000072 877234000072 0877234000072
GMDN Terms# Term, Definition table Term Definition Arteriovenous shunt A surgically-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 ateriovenous fistula or for patients who have exhausted peripheral venous access. Disposable devices associated with implantation may be included. This is a single-use device.
Device Sizes# Type, Value, Unit table Type Value Unit Length 53 Centimeter Lumen/Inner Diameter 6 Millimeter Outer Diameter 7.4 Millimeter
Storage And Handling# Type, Low, High table Type Low High Condition Special Storage Condition, Specify 0 0 Keep Dry and Out of Direct Sunlight Storage Environment Temperature 15 Degrees Celsius 30 Degrees Celsius
Regulatory Flags# DUNS number 119253177 Device count 1 Lot or batch true Expiration date on label true No natural rubber latex true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 00877234001635 PhotoFix Decellularized Bovine Pericardium PFP6X8 PFP6X8 2026-05-29 00877234001642 PhotoFix Decellularized Bovine Pericardium PFP0.8X8 PFP0.8X8 2026-05-29 00877234001659 PhotoFix Decellularized Bovine Pericardium PFP1X6 PFP1X6 2026-05-29 00877234001666 PhotoFix Decellularized Bovine Pericardium PFP4X4 PFP4X4 2026-05-29 00877234001673 PhotoFix Decellularized Bovine Pericardium PFP2X9 PFP2X9 2026-05-29 00877234001680 PhotoFix Decellularized Bovine Pericardium PFP1X10 PFP1X10 2026-05-29 00877234001697 PhotoFix Decellularized Bovine Pericardium PFP1X14 PFP1X14 2026-05-29 00877234001703 PhotoFix Decellularized Bovine Pericardium PFP8X14 PFP8X14 2026-05-29 00877234000096 CardioGenesis NS2000 LSR-SG2100S 2016-12-12 00877234000447 CryoValve® SG Pulmonary Human Heart Valve SGPV00 SGPV00 2015-09-11 00877234000454 CryoValve® SG Pulmonary Human Heart Valve SGPV10 SGPV10 2015-09-11 00877234000102 CardioGenesis HP-SG3 HP-SG3 2016-12-12 00877234001192 "AMDS Hybrid Prosthesis (""AMDS"")" K039420 AMDS40 2025-02-05 00877234001208 "AMDS Hybrid Prosthesis (""AMDS"")" K039421 AMDS4030 2025-02-05 00877234001215 "AMDS Hybrid Prosthesis (""AMDS"")" K039422 AMDS55 2025-02-05 00877234001222 "AMDS Hybrid Prosthesis (""AMDS"")" K039423 AMDS5540 2025-02-05 00877234001321 "AMDS Hybrid Prosthesis (""AMDS"")" K038896 AMDS4030c 2025-02-05 00877234001338 "AMDS Hybrid Prosthesis (""AMDS"")" K038895 AMDS40c 2025-02-05 10877234001298 BioGlue Surgical Adhesive BG3510-5-US BG3510-5-US 2024-03-13 10877234001304 BioGlue Surgical Adhesive BG3515-5-US BG3515-5-US 2024-03-13
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