Aurora Plasmapheresis System 6R4601

GUDID 04086000100236

Automated plasmapheresis system designed to collect virtually cell-free plasma by membrane filtration using single-use disposable sets. Collected plas

Fresenius Kabi AG

Apheresis system

• Primary Device ID: 04086000100236
• NIH Device Record Key: 2b41ab1c-ca0c-4d6d-8c55-54eb29e3c6cd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Aurora Plasmapheresis System
• Version Model Number: 6R4601
• Catalog Number: 6R4601
• 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: 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	04086000100236 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• BK110072

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: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-05

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