HeRO® Graft Accessory Component Kit

FDA UDI

Class II (US FDA UDI)

by Artivion, Inc.

Identity

Trade Name: HeRO® Graft Accessory Component Kit FDA UDI
Generic Name: Arteriovenous shunt FDA UDI
Device Name: 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. FDA UDI
Model / Reference: HERO 1003 FDA UDI
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. FDA UDI

Identifiers

Catalog Number: HERO 1003 FDA UDI
Primary DI / UDI-DI: 00877234000089 FDA UDI
FDA Product Code: MSD FDA UDI
LJS FDA UDI
DSY FDA UDI
GMDN Term: Arteriovenous shunt FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 876.5540 FDA UDI
880.5970 FDA UDI
870.3450 FDA UDI
Commercial Distribution: Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

MRI Safety

MR Conditional FDA UDI

HeRO® Graft Accessory Component Kit by Artivion, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Artivion, Inc.

Sources (1)

FDA UDI 0348aa70-454f-4096-b241-19dac357573f 38 fields · synced Jun 8, 2026