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HeRO® Graft Venous Outflow Component

FDA UDI

Class II (US FDA UDI)

by Artivion, Inc.

Identity

Trade Name
HeRO® Graft Venous Outflow Component 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 Venous Outflow Component has a 5mm inner diameter (ID), 19F outer diameter (OD), and is 40cm long. It consists of radiopaque silicone with braided nitinol reinforcement (for kink and crush resistance) and a radiopaque marker band at the tip. FDA UDI
Model / Reference
HERO 1001 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 Venous Outflow Component has a 5mm inner diameter (ID), 19F outer diameter (OD), and is 40cm long. It consists of radiopaque silicone with braided nitinol reinforcement (for kink and crush resistance) and a radiopaque marker band at the tip. FDA UDI

Identifiers

Catalog Number
HERO 1001 FDA UDI
Primary DI / UDI-DI
00877234000065 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

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI
MRI Safety
MR Conditional FDA UDI

Dimensions & Sizes

Size
Lumen/Inner Diameter — 5 Millimeter FDA UDI
Length — 40 Centimeter FDA UDI

HeRO® Graft Venous Outflow Component 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

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Manufacturer

Manufacturer
Artivion, Inc.

Sources (1)

  • FDA UDI 564f4c76-b11c-49fb-bb58-f4e0f69e3099 38 fields · synced Jun 8, 2026