Aurora Software Version 2.1C Upgrade X6S4021USB

GUDID 00810020440300

AURORA Software Version 2.1C for collection of plasma by membrane filtration.

Fresenius Kabi AG

Apheresis system Apheresis system Apheresis system Apheresis system Apheresis system Apheresis system Apheresis system Apheresis system Apheresis system Apheresis system Apheresis system Apheresis system Apheresis system Apheresis system Apheresis system Apheresis system

• Primary Device ID: 00810020440300
• NIH Device Record Key: ddb48358-d4b5-44b0-9e3f-672bb175f07c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Aurora Software Version 2.1C Upgrade
• Version Model Number: Version 2.1C
• Catalog Number: X6S4021USB
• 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: true
• 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	00810020440300 [Primary]
GS1	10810020440307 [Package]; Package: Carton [3 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• BK190368

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: 2021-06-17
• Device Publish Date: 2021-06-09

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