Ellipsys Vascular Access System AMI6005 CE

GUDID 00763000496982

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 Electrocautery system, line-powered Electrocautery system, line-powered Electrocautery system, line-powered Electrocautery system, line-powered Electrocautery system, line-powered Electrocautery system, line-powered Electrocautery system, line-powered Electrocautery system, line-powered Electrocautery system, line-powered Electrocautery system, line-powered Electrocautery system, line-powered Electrocautery system, line-powered Electrocautery system, line-powered Electrocautery system, line-powered
Primary Device ID00763000496982
NIH Device Record Keyd91824da-543e-44ed-8460-a578d5f4169a
Commercial Distribution StatusIn Commercial Distribution
Brand NameEllipsys Vascular Access System
Version Model NumberAMI6005
Catalog NumberAMI6005 CE
Company DUNS053562774
Company NameAVENU MEDICAL, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1-949-276-2483
Emailcustomerservice@avenumedical.com
Phone+1-949-276-2483
Emailcustomerservice@avenumedical.com
Phone+1-949-276-2483
Emailcustomerservice@avenumedical.com
Phone+1-949-276-2483
Emailcustomerservice@avenumedical.com
Phone+1-949-276-2483
Emailcustomerservice@avenumedical.com
Phone+1-949-276-2483
Emailcustomerservice@avenumedical.com
Phone+1-949-276-2483
Emailcustomerservice@avenumedical.com
Phone+1-949-276-2483
Emailcustomerservice@avenumedical.com
Phone+1-949-276-2483
Emailcustomerservice@avenumedical.com
Phone+1-949-276-2483
Emailcustomerservice@avenumedical.com
Phone+1-949-276-2483
Emailcustomerservice@avenumedical.com
Phone+1-949-276-2483
Emailcustomerservice@avenumedical.com
Phone+1-949-276-2483
Emailcustomerservice@avenumedical.com
Phone+1-949-276-2483
Emailcustomerservice@avenumedical.com
Phone+1-949-276-2483
Emailcustomerservice@avenumedical.com

Device Dimensions

Catheter Gauge6 French
Catheter Gauge6 French
Catheter Gauge6 French
Catheter Gauge6 French
Catheter Gauge6 French
Catheter Gauge6 French
Catheter Gauge6 French
Catheter Gauge6 French
Catheter Gauge6 French
Catheter Gauge6 French
Catheter Gauge6 French
Catheter Gauge6 French
Catheter Gauge6 French
Catheter Gauge6 French
Catheter Gauge6 French

Operating and Storage Conditions

Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100763000496982 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

PQKPercutaneous Catheter For Creation Of An Arteriovenous Fistula For Hemodialysis Access

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-02-16
Device Publish Date2021-02-08

On-Brand Devices [Ellipsys Vascular Access System]

B357AMI6050The Ellipsys Vascular Access System is indicated for the creation of a proximal radial artery to
B357AMI6005The Ellipsys® Vascular Access System is indicated for the creation of a proximal radial artery
00763000496982The Ellipsys® Vascular Access System is indicated for the creation of a proximal radial artery
00763000496975The Ellipsys® Vascular Access System is indicated for the creation of a proximal radial artery
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.