AMICUS Separator Software

GUDID 04086000101912

Software version for Amicus Separator

Fresenius Kabi AG

Apheresis system

• Primary Device ID: 04086000101912
• NIH Device Record Key: 6513e3ad-4cbd-4515-b5bf-250f941e1ab3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AMICUS Separator Software
• Version Model Number: 6.0
• 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	04086000101912 [Primary]

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: 2020-01-29
• Device Publish Date: 2020-01-21

On-Brand Devices [AMICUS Separator Software]

• 04086000101660: Software version for Amicus Separator.
• 04086000101653: Software version for Amicus Separator.
• 04086000101912: Software version for Amicus Separator