AMICUS Separator Life Extension Software

GUDID 00810020441192

Software version for AMICUS Separator Life Extension Device

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 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 Apheresis system

• Primary Device ID: 00810020441192
• NIH Device Record Key: 1f517965-62db-41b5-8f76-c3d7494419bb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AMICUS Separator Life Extension Software
• Version Model Number: 6.1
• 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: 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	00810020441192 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• BK230824

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: 2023-06-01
• Device Publish Date: 2023-05-24

On-Brand Devices [AMICUS Separator Life Extension Software]

• 00810020441192: Software version for AMICUS Separator Life Extension Device
• 00810020440607: Software version for AMICUS Separator Life Extension Device