Home GUDID 00877234000089
HeRO® Graft Accessory Component Kit
Primary DI 00877234000089
Brand HeRO® Graft Accessory Component Kit
Company Artivion, Inc.
Model HERO 1003
Catalog number HERO 1003
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 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.
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 00877234000089 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 00877234000089 00877234000089 877234000089 0877234000089
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 Device Size Text, specify 0 Device Size Text, specify 0 Device Size Text, specify 0 Device Size Text, specify 0 Device Size Text, specify 0 Device Size Text, specify 0 Device Size Text, specify 0 Device Size Text, specify 0 Device Size Text, specify 0 Device Size Text, specify 0 Device Size Text, specify 0 Device Size Text, specify 0 Device Size Text, specify 0 Device Size Text, specify 0
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 Kit true 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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