Aurora Xi

GUDID 00810020440560

Aurora Xi Plasmapheresis System with Software Version 2.1

Fresenius Kabi AG

Apheresis system

• Primary Device ID: 00810020440560
• NIH Device Record Key: db01c770-082e-4754-a8e1-42d9eb6960dc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Aurora Xi
• Version Model Number: Software Version 2.1
• Company DUNS: 315654579
• Company Name: Fresenius Kabi AG
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: false
• Manufacturing Date: false
• 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	00810020440560 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• BK241135

FDA Product Code

• GKT: Separator, Automated, Blood Cell, Diagnostic

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: 2025-03-06
• Device Publish Date: 2025-02-26

On-Brand Devices [Aurora Xi]

• 00810020442199: Aurora Xi Plasmapheresis System with Software Version 2.0
• 00810020440560: Aurora Xi Plasmapheresis System with Software Version 2.1