HeRO® Graft Accessory Component Kit HERO 1003
GUDID 00877234000089
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.
Cryolife, Inc.
Arteriovenous shunt| Primary Device ID | 00877234000089 |
| NIH Device Record Key | 0348aa70-454f-4096-b241-19dac357573f |
| Commercial Distribution Discontinuation | 2016-06-22 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | HeRO® Graft Accessory Component Kit |
| Version Model Number | HERO 1003 |
| Catalog Number | HERO 1003 |
| Company DUNS | 119253177 |
| Company Name | Cryolife, Inc. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Conditional |
| Human Cell/Tissue Product | false |
| Device Kit | true |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | 770-419-3355 |
| custsvc@cryolife.com | |
| Phone | 770-419-3355 |
| custsvc@cryolife.com | |
| Phone | 770-419-3355 |
| custsvc@cryolife.com | |
| Phone | 770-419-3355 |
| custsvc@cryolife.com | |
| Phone | 770-419-3355 |
| custsvc@cryolife.com | |
| Phone | 770-419-3355 |
| custsvc@cryolife.com | |
| Phone | 770-419-3355 |
| custsvc@cryolife.com | |
| Phone | 770-419-3355 |
| custsvc@cryolife.com | |
| Phone | 770-419-3355 |
| custsvc@cryolife.com | |
| Phone | 770-419-3355 |
| custsvc@cryolife.com | |
| Phone | 770-419-3355 |
| custsvc@cryolife.com | |
| Phone | 770-419-3355 |
| custsvc@cryolife.com | |
| Phone | 770-419-3355 |
| custsvc@cryolife.com |
Device Dimensions
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Operating and Storage Conditions
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry and Out of Direct Sunlight |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry and Out of Direct Sunlight |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry and Out of Direct Sunlight |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry and Out of Direct Sunlight |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry and Out of Direct Sunlight |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry and Out of Direct Sunlight |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry and Out of Direct Sunlight |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry and Out of Direct Sunlight |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry and Out of Direct Sunlight |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry and Out of Direct Sunlight |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00877234000089 [Primary] |
FDA Product Code
| MSD | Catheter, Hemodialysis, Implanted |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-03-29 |
| Device Publish Date | 2015-09-23 |
Devices Manufactured by Cryolife, Inc.
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| 00877234000447 - CryoValve® SG Pulmonary Human Heart Valve | 2018-07-24 Pulmonary Valve and Conduit SG The CryoValve SG Pulmonary Human Heart Valve is a human heart valve aseptically recovered from do |
| 00877234000454 - CryoValve® SG Pulmonary Human Heart Valve | 2018-07-24 Pulmonary Valve SG The CryoValve SG Pulmonary Human Heart Valve is a human heart valve aseptically recovered from donated human |
| 00877234000096 - CardioGenesis | 2018-07-06 SolarGen 2100s Holmium:YAG Laser Console |
| 00877234000102 - CardioGenesis | 2018-07-06 SoloGrip III Handpiece Delivery System |
| 00877234000119 - CardioGenesis | 2018-07-06 Pearl 5.0 Handpiece Delivery System |
| 10877234000154 - BioGlue Surgical Adhesive | 2018-07-06 BioGlue Surgical Adhesive Applicator Tips |
| 00877234000164 - BioGlue Surgical Adhesive | 2018-07-06 BioGlue Surgical Adhesive Syringe Extender Tips |
Trademark Results [HeRO]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 HERO 98753953 not registered Live/Pending |
HYPRLABS Inc. 2024-09-17 |
 HERO 98694356 not registered Live/Pending |
Youcopia Products, Inc. 2024-08-12 |
 HERO 98658180 not registered Live/Pending |
AryaBall, LLC 2024-07-19 |
 HERO 98625974 not registered Live/Pending |
DZONE IP Holding, LLC 2024-06-29 |
 HERO 98580069 not registered Live/Pending |
HERO LLC 2024-06-01 |
 HERO 98508426 not registered Live/Pending |
UFP Industries, Inc. 2024-04-18 |
 HERO 98465770 not registered Live/Pending |
Hero & Company LLC 2024-03-25 |
 HERO 98438417 not registered Live/Pending |
MegaCorp Logistics, LLC 2024-03-07 |
 HERO 98425873 not registered Live/Pending |
Atlantic Filter Corporation 2024-02-28 |
 HERO 98401586 not registered Live/Pending |
Revival Animal Health, LLC 2024-02-12 |
 HERO 98356687 not registered Live/Pending |
HERO LLC 2024-01-14 |
 HERO 98073449 not registered Live/Pending |
TKE Distribution LLC 2023-07-06 |
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