Ellipsys Vascular Access System

GUDID B357AMI6005

The Ellipsys® Vascular Access System is indicated for the creation of a proximal radial artery to perforating vein anastomosis via a retrograde venous

AVENU MEDICAL, INC.

Electrocautery system, line-powered

• Primary Device ID: B357AMI6005
• NIH Device Record Key: 9208b842-19d8-4eda-8c89-bf428a3dc0a0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ellipsys Vascular Access System
• Version Model Number: AMI6005
• Company DUNS: 053562774
• Company Name: AVENU MEDICAL, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• 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: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(949)-276-2483
• Email: customerservice@avenumedical.c
• Phone: +1(949)-276-2483
• Email: customerservice@avenumedical.c

Device Dimensions

• Catheter Gauge: 6 French
• Catheter Gauge: 6 French

Operating and Storage Conditions

• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B357AMI6005 [Primary]

FDA Product Code

• PQK: Percutaneous Catheter For Creation Of An Arteriovenous Fistula For Hemodialysis Access

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: 2019-01-29
• Device Publish Date: 2018-10-24

On-Brand Devices [Ellipsys Vascular Access System]

• B357AMI6050: The Ellipsys Vascular Access System is indicated for the creation of a proximal radial artery to
• B357AMI6005: The Ellipsys® Vascular Access System is indicated for the creation of a proximal radial artery
• 00763000496982: The Ellipsys® Vascular Access System is indicated for the creation of a proximal radial artery
• 00763000496975: The Ellipsys® Vascular Access System is indicated for the creation of a proximal radial artery