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.

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• Primary Device ID: 00763000478193
• NIH Device Record Key: 942db7c3-394f-4775-86a4-0040b12a2773
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00763000478193 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K191114

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: 2021-02-04
• Device Publish Date: 2021-01-27

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