Aurora Xi Plasmapheresis System 6R4612R

GUDID 00810020440676

For collection of plasma by membrane filtration. For use with the Plasmacell Xi disposable sets.

Fresenius Kabi AG

Apheresis system

• Primary Device ID: 00810020440676
• NIH Device Record Key: 089c47e1-b968-4ee9-870e-52f8c2fbd8dd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Aurora Xi Plasmapheresis System
• Version Model Number: 6R4612R
• Catalog Number: 6R4612R
• 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.
• 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	00810020440676 [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: 2022-02-21
• Device Publish Date: 2022-02-11

Devices Manufactured by Fresenius Kabi AG

• 10810020441380 - Plasmalink Bottle 1000 mL with locking luer adapter: 2025-01-23 For the collection of blood components. Sterile Fluid Path
• 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