ALYX Component Collection System 6R5725

GUDID 04086000100212

Intended for use in blood collection establishments to collect and separate whole blood into its components.

Fresenius Kabi AG

Apheresis system

• Primary Device ID: 04086000100212
• NIH Device Record Key: 34600ecc-0497-4fd9-b490-3873d9d3ef0b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ALYX Component Collection System
• Version Model Number: 6R5725
• Catalog Number: 6R5725
• 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	04086000100212 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• BK010033

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: 2016-09-08

Devices Manufactured by Fresenius Kabi AG

• 10810020440512 - Adaptive Nomogram Transfer Pack: 2024-12-20 For processing and/or storage of blood and blood components. Sterile Fluid Path
• 00811505030450 - Ivenix Infusion System: 2024-12-16 Infusion Management System (IMS)
• 00811505030467 - Ivenix Infusion System: 2024-12-16 Large Volume Pump (LVP) Software (order 1 per pump)
• 14086000100059 - AMICUS Apheresis Kit – Single Needle with Platelet Additive Solution Connector: 2024-11-07 For Collection of Platelets with Optional Plasma and/or Red Blood Cells. For Platelet Storage in Plasma or Platelet Additive Sol
• 04086000860888 - COMPOGUARD Advance Basic: 2024-11-07 Device, Blood Mixing and Weighing
• 04086000860895 - COMPOGUARD Advance Data: 2024-11-06 Device, Blood Mixing and Weighing
• 04086000860901 - COMPOGUARD Advance COMPLETE: 2024-11-06 Device, Blood Mixing and Weighing
• 00810020440591 - AMICUS Separator Legacy Software: 2024-04-04 Software version for AMICUS Separator Legacy Device