Ellipsys Power Controller

GUDID B357AMI1001

The Ellipsys® Power Controller is the reusable control unit for the Ellipsys® Vascular Access System. The Controller is a portable electronic console

AVENU MEDICAL, INC.

Electrocautery system, line-powered

• Primary Device ID: B357AMI1001
• NIH Device Record Key: cc6d2f61-7670-4a26-9fa2-126ce1c3b003
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ellipsys Power Controller
• Version Model Number: AMI1001
• Company DUNS: 053562774
• Company Name: AVENU MEDICAL, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• 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.c
• Phone: +1(949)-276-2483
• Email: customerservice@avenumedical.c

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B357AMI1001 [Primary]

FDA Product Code

• PQK: Percutaneous Catheter For Creation Of An Arteriovenous Fistula For Hemodialysis Access

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2018-11-26
• Device Publish Date: 2018-10-24

On-Brand Devices [Ellipsys Power Controller]

• B357AMI1001: The Ellipsys® Power Controller is the reusable control unit for the Ellipsys® Vascular Access
• B357AMI1000: AMI1000
• 00763000478193: The Ellipsys® Power Controller is the reusable control unit for the Ellipsys® Vascular Access
• 00763000574710: The Ellipsys® Power Controller is the reusable control unit for the Ellipsys® Vascular Access