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 Electrocautery system, line-powered
Primary Device IDB357AMI6005
NIH Device Record Key9208b842-19d8-4eda-8c89-bf428a3dc0a0
Commercial Distribution StatusIn Commercial Distribution
Brand NameEllipsys Vascular Access System
Version Model NumberAMI6005
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.c
Phone+1(949)-276-2483
Emailcustomerservice@avenumedical.c

Device Dimensions

Catheter Gauge6 French
Catheter Gauge6 French

Operating and Storage Conditions

Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB357AMI6005 [Primary]

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 StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2019-01-29
Device Publish Date2018-10-24

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

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