HeRO® Graft Adapter HERO 1004

GUDID 00877234000423

The HeRO (Hemodialysis Reliable Outflow) Graft is a longterm 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. The HeRO Graft traverses central venous stenosis allowing for long-term hemodialysis access. HeRO Graft consists of a proprietary Venous Outflow Component and only one of the following options: • The Arterial Graft Component (not included) • The Adapter (a separate commercially available 6mm ID vascular graft is not included with the Adapter) The Venous Outflow Component (not included) 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. The Adapter connects a 6mm ID vascular graft (not included) to the Venous Outflow Component. The Adapter (titanium) has a tapered ID (6mm to 5mm) to provide a smooth transition from a 6mm ID vascular graft to the 5mm ID Venous Outflow Component. A disposable Graft Expander is provided to aid in connecting a 6mm ID vascular graft to the Adapter. See Instructions for Use for further details regarding the grafts permitted for use with the Adapter.

Cryolife, Inc.

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Primary Device ID00877234000423
NIH Device Record Key6421bad5-6ae4-44a9-bac3-ae1e06c716e3
Commercial Distribution Discontinuation2016-06-22
Commercial Distribution StatusNot in Commercial Distribution
Brand NameHeRO® Graft Adapter
Version Model NumberHERO 1004
Catalog NumberHERO 1004
Company DUNS119253177
Company NameCryolife, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone770-419-3355
Emailcustsvc@cryolife.com
Phone770-419-3355
Emailcustsvc@cryolife.com
Phone770-419-3355
Emailcustsvc@cryolife.com
Phone770-419-3355
Emailcustsvc@cryolife.com
Phone770-419-3355
Emailcustsvc@cryolife.com
Phone770-419-3355
Emailcustsvc@cryolife.com
Phone770-419-3355
Emailcustsvc@cryolife.com
Phone770-419-3355
Emailcustsvc@cryolife.com
Phone770-419-3355
Emailcustsvc@cryolife.com
Phone770-419-3355
Emailcustsvc@cryolife.com
Phone770-419-3355
Emailcustsvc@cryolife.com
Phone770-419-3355
Emailcustsvc@cryolife.com
Phone770-419-3355
Emailcustsvc@cryolife.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry and Out of Direct Sunlight
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry and Out of Direct Sunlight
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry and Out of Direct Sunlight
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry and Out of Direct Sunlight
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry and Out of Direct Sunlight
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry and Out of Direct Sunlight
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry and Out of Direct Sunlight
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry and Out of Direct Sunlight
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry and Out of Direct Sunlight
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry and Out of Direct Sunlight
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100877234000423 [Primary]

FDA Product Code

MSDCatheter, Hemodialysis, Implanted

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2015-11-23

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Trademark Results [HeRO]

Mark Image

Registration | Serial
Company
Trademark
Application Date
HERO
HERO
98465770 not registered Live/Pending
Hero & Company LLC
2024-03-25
HERO
HERO
98438417 not registered Live/Pending
MegaCorp Logistics, LLC
2024-03-07
HERO
HERO
98425873 not registered Live/Pending
Atlantic Filter Corporation
2024-02-28
HERO
HERO
98401586 not registered Live/Pending
Revival Animal Health, LLC
2024-02-12
HERO
HERO
98356687 not registered Live/Pending
HERO LLC
2024-01-14
HERO
HERO
98073449 not registered Live/Pending
TKE Distribution LLC
2023-07-06
HERO
HERO
98023677 not registered Live/Pending
Aquatech International, LLC
2023-06-01
HERO
HERO
97933422 not registered Live/Pending
DNVB Inc.
2023-05-12
HERO
HERO
97864167 not registered Live/Pending
Demand IQ, Inc
2023-03-30
HERO
HERO
97772810 not registered Live/Pending
MagicX Inc.
2023-01-30
HERO
HERO
97759255 not registered Live/Pending
Top Shelf Enterprises, LLC
2023-01-18
HERO
HERO
97732861 not registered Live/Pending
Sandra Alicia Robbie
2022-12-27

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