Ellipsys Power Controller

GUDID B357AMI1000

AVENU MEDICAL, INC.

Electrocautery system, line-powered
Primary Device IDB357AMI1000
NIH Device Record Key95d89ebe-cd45-4731-bd39-6897aab42aa8
Commercial Distribution StatusIn Commercial Distribution
Brand NameEllipsys Power Controller
Version Model NumberAMI1000
Company DUNS053562774
Company NameAVENU MEDICAL, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone949-276-2483
Emaildcampbell@avenumedical.com
Phone949-276-2483
Emaildcampbell@avenumedical.com

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB357AMI1000 [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 Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2018-10-19
Device Publish Date2018-09-18

On-Brand Devices [Ellipsys Power Controller]

B357AMI1001The Ellipsys® Power Controller is the reusable control unit for the Ellipsys® Vascular Access
B357AMI1000AMI1000
00763000478193The Ellipsys® Power Controller is the reusable control unit for the Ellipsys® Vascular Access
00763000574710The Ellipsys® Power Controller is the reusable control unit for the Ellipsys® Vascular Access

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