AMICUS Separator 6R4590TH-T

GUDID 00810020440232

The AMICUS Separator is an automated blood cell separator indicated for the collection of blood components and in therapeutic apheresis.

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

• Primary Device ID: 00810020440232
• NIH Device Record Key: bfd7adbe-ead9-44c9-8a76-257c8b4c13c1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AMICUS Separator
• Version Model Number: 6R4590TH-T
• Catalog Number: 6R4590TH-T
• 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

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Storage and Handling as defined on Label
• Special Storage Condition, Specify: Between 0 and 0 *Storage and Handling as defined on Label
• Special Storage Condition, Specify: Between 0 and 0 *Storage and Handling as defined on Label
• Special Storage Condition, Specify: Between 0 and 0 *Storage and Handling as defined on Label
• Special Storage Condition, Specify: Between 0 and 0 *Storage and Handling as defined on Label
• Special Storage Condition, Specify: Between 0 and 0 *Storage and Handling as defined on Label
• Special Storage Condition, Specify: Between 0 and 0 *Storage and Handling as defined on Label
• Special Storage Condition, Specify: Between 0 and 0 *Storage and Handling as defined on Label
• Special Storage Condition, Specify: Between 0 and 0 *Storage and Handling as defined on Label
• Special Storage Condition, Specify: Between 0 and 0 *Storage and Handling as defined on Label
• Special Storage Condition, Specify: Between 0 and 0 *Storage and Handling as defined on Label

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810020440232 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K200530

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: 2020-10-28
• Device Publish Date: 2020-10-20

On-Brand Devices [AMICUS Separator]

• 04086000100137: Automated blood cell separator indicated for the collection of blood components and in therapeut
• 04086000100120: Automated blood cell separator indicated for the collection of blood components and in therapeut
• 00810020440232: The AMICUS Separator is an automated blood cell separator indicated for the collection of blood
• 00810020440249: The AMICUS Separator is an automated blood cell separator indicated for the collection of blood
• 00810020440218: The AMICUS Separator is an automated blood cell separator indicated for the collection of blood