AccessGUDID - DEVICE: Artegraft Vascular Graft (00316837000329)

GUDID

Device Identifier (DI) Information

Brand Name: Artegraft Vascular Graft
Version or Model: AG 840
Commercial Distribution Status: In Commercial Distribution
Catalog Number: AG 840
Company Name: Artegraft Inc

Primary DI Number: 00316837000329
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 003683646 *Terms of Use

Device Description: 7mm x 40 cm

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name	GMDN Definition
Arteriovenous shunt	A 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.

GMDN Preferred Term Name

GMDN Definition

Arteriovenous shunt

A 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.

FDA Product Code

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Product Code	Product Code Name
LXA	Tissue Graft Of 6mm And Greater

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
N16837	015

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: f389b581-3924-4ba7-9cf9-35fcd3094c9b
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: August 29, 2014