HeRO® Graft Arterial Graft Component

Primary DI
00877234000072
Brand
HeRO® Graft Arterial Graft Component
Company
Artivion, Inc.
Model
HERO 1002
Catalog number
HERO 1002
Device 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 ComponentThe 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.
Published
2015-09-23
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DSYProsthesis, Vascular Graft, Of 6mm And Greater Diameter
LJSCatheter,Intravascular,Therapeutic,Long-Term Greater Than 30 Days
MSDCatheter, Hemodialysis, Implanted

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DSYProsthesis, Vascular Graft, Of 6mm And Greater DiameterCardiovascular2
LJSCatheter, Intravascular, Therapeutic, Long-Term Greater Than 30 DaysGeneral Hospital2
MSDCatheter, Hemodialysis, ImplantedGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00877234000072PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00877234000072008772340000728772340000720877234000072

GMDN Terms#

Term, Definition table
TermDefinition
Arteriovenous shuntA surgically-implanted device designed to provide a passage for blood to flow between an artery typically located in an arm, and a peripheral vein, central vein or right atrium, creating a graft fistula that provides blood access for external procedures, especially haemodialysis. It is a synthetic vascular graft/graft assembly with a thin wall and appropriate size (commonly 6 mm diameter) and configuration to facilitate vessel puncturing. It is typically used when it is not possible or convenient to create a direct ateriovenous fistula or for patients who have exhausted peripheral venous access. Disposable devices associated with implantation may be included. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length53Centimeter
Lumen/Inner Diameter6Millimeter
Outer Diameter7.4Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep Dry and Out of Direct Sunlight
Storage Environment Temperature15 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
770-419-3355custsvc@cryolife.com

Regulatory Flags#

DUNS number
119253177
Device count
1
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

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