Ellipsys Power Controller

GUDID 00763000478193

The Ellipsys® Power Controller is the reusable control unit for the Ellipsys® Vascular Access System. The Controller is a portable electronic console with AC power input, internal control electronics, a Catheter connection receptacle, and LCD display. The Controller delivers power to the Catheter heating element and guides the user through the procedure with visual prompts. The power controller is only compatible with the Avenu Medical Ellipsys® Catheter.

AVENU MEDICAL, INC.

Electrocautery system, line-powered
Primary Device ID00763000478193
NIH Device Record Key942db7c3-394f-4775-86a4-0040b12a2773
Commercial Distribution StatusIn Commercial Distribution
Brand NameEllipsys Power Controller
Version Model NumberAMI1001
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100763000478193 [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 Date2021-02-04
Device Publish Date2021-01-27

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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