Aurora Xi Plasmapheresis System

GUDID 00810020440898

Software Version 1.3 for Aurora Xi

Fresenius Kabi AG

Apheresis system

• Primary Device ID: 00810020440898
• NIH Device Record Key: 333fbbdc-dc80-4c80-bc2b-3215b00d814f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Aurora Xi Plasmapheresis System
• Version Model Number: 1.3
• 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	00810020440898 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• BK220788

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: 2023-02-27
• Device Publish Date: 2023-02-17

On-Brand Devices [Aurora Xi Plasmapheresis System]

• 04086000101967: Aurora Xi Plasmapheresis System Software Version 1.2
• 04086000101523: For collection of plasma by membrane filtration.For Use With the Plasmacell Xi Disposable Sets.
• 00810020440898: Software Version 1.3 for Aurora Xi