Ellipsys Vascular Access System AMI6005 US

GUDID 00763000496975

The Ellipsys® Vascular Access System is indicated for the creation of a proximal radial artery to perforating vein anastomosis via a retrograde venous access approach in patients with a minimum vessel diameter of 2.0mm and less than 1.5mm of separation between the artery and vein at the fistula creation site who have chronic kidney disease requiring dialysis. The main components of the Ellipsys Vascular Access System are the Ellipsys Catheter, the Ellipsys Crossing Needle, and the Ellipsys Power Controller. The Crossing Needle and Catheter are single-use, sterile disposables. The Ellipsys Power Controller is a reusable, non-sterile portable electronic console that is packaged and provided separately.

AVENU MEDICAL, INC.

Electrocautery system, line-powered

• Primary Device ID: 00763000496975
• NIH Device Record Key: 376170ff-cc73-4f37-88e2-0d1eeb0ece19
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ellipsys Vascular Access System
• Version Model Number: AMI6005
• Catalog Number: AMI6005 US
• 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.com
• Phone: +1-949-276-2483
• Email: customerservice@avenumedical.com
• Phone: +1-949-276-2483
• Email: customerservice@avenumedical.com
• Phone: +1-949-276-2483
• Email: customerservice@avenumedical.com
• Phone: +1-949-276-2483
• Email: customerservice@avenumedical.com
• Phone: +1-949-276-2483
• Email: customerservice@avenumedical.com
• Phone: +1-949-276-2483
• Email: customerservice@avenumedical.com
• Phone: +1-949-276-2483
• Email: customerservice@avenumedical.com
• Phone: +1-949-276-2483
• Email: customerservice@avenumedical.com
• Phone: +1-949-276-2483
• Email: customerservice@avenumedical.com
• Phone: +1-949-276-2483
• Email: customerservice@avenumedical.com
• Phone: +1-949-276-2483
• Email: customerservice@avenumedical.com
• Phone: +1-949-276-2483
• Email: customerservice@avenumedical.com
• Phone: +1-949-276-2483
• Email: customerservice@avenumedical.com
• Phone: +1-949-276-2483
• Email: customerservice@avenumedical.com

Device Dimensions

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

Operating and Storage Conditions

• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00763000496975 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K191114

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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-02-16
• Device Publish Date: 2021-02-08

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