HeRO® Graft Arterial Graft Component HERO 1002

GUDID 00877234000072

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 Arterial Graft Component has a 6mm ID, 7.4mm OD, and is 53cm long, inclusive of the connector. It consists of an ePTFE hemodialysis graft with PTFE beading to provide kink resistance near the titanium connector. The titanium connector attaches the Arterial Graft Component to the HeRO Graft Venous Outflow Component. The HeRO Graft Arterial Graft Component is cannulated using standard technique according to KDOQI guidelines.

Cryolife, Inc.

Arteriovenous shunt

• Primary Device ID: 00877234000072
• NIH Device Record Key: 33b23bc3-aac4-498c-9a57-8533868523f1
• Commercial Distribution Discontinuation: 2016-06-22
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: HeRO® Graft Arterial Graft Component
• Version Model Number: HERO 1002
• Catalog Number: HERO 1002
• 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: false
• 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
• Email: custsvc@cryolife.com
• Phone: 770-419-3355
• Email: custsvc@cryolife.com
• Phone: 770-419-3355
• Email: custsvc@cryolife.com
• Phone: 770-419-3355
• Email: custsvc@cryolife.com
• Phone: 770-419-3355
• Email: custsvc@cryolife.com
• Phone: 770-419-3355
• Email: custsvc@cryolife.com
• Phone: 770-419-3355
• Email: custsvc@cryolife.com
• Phone: 770-419-3355
• Email: custsvc@cryolife.com
• Phone: 770-419-3355
• Email: custsvc@cryolife.com
• Phone: 770-419-3355
• Email: custsvc@cryolife.com
• Phone: 770-419-3355
• Email: custsvc@cryolife.com
• Phone: 770-419-3355
• Email: custsvc@cryolife.com
• Phone: 770-419-3355
• Email: custsvc@cryolife.com

Device Dimensions

• Length: 53 Centimeter
• Length: 53 Centimeter
• Length: 53 Centimeter
• Outer Diameter: 7.4 Millimeter
• Lumen/Inner Diameter: 6 Millimeter
• Length: 53 Centimeter
• Outer Diameter: 7.4 Millimeter
• Lumen/Inner Diameter: 6 Millimeter
• Length: 53 Centimeter
• Outer Diameter: 7.4 Millimeter
• Lumen/Inner Diameter: 6 Millimeter
• Length: 53 Centimeter
• Outer Diameter: 7.4 Millimeter
• Lumen/Inner Diameter: 6 Millimeter
• Length: 53 Centimeter
• Outer Diameter: 7.4 Millimeter
• Lumen/Inner Diameter: 6 Millimeter
• Length: 53 Centimeter
• Outer Diameter: 7.4 Millimeter
• Lumen/Inner Diameter: 6 Millimeter
• Length: 53 Centimeter
• Outer Diameter: 7.4 Millimeter
• Lumen/Inner Diameter: 6 Millimeter
• Length: 53 Centimeter
• Outer Diameter: 7.4 Millimeter
• Lumen/Inner Diameter: 6 Millimeter
• Length: 53 Centimeter
• Outer Diameter: 7.4 Millimeter
• Lumen/Inner Diameter: 6 Millimeter
• Length: 53 Centimeter
• Outer Diameter: 7.4 Millimeter
• Lumen/Inner Diameter: 6 Millimeter
• Length: 53 Centimeter

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	00877234000072 [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

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