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 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: 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

• 00810020440591 - AMICUS Separator Legacy Software: 2024-04-04 Software version for AMICUS Separator Legacy Device
• 00810020440607 - AMICUS Separator Life Extension Software: 2024-04-04 Software version for AMICUS Separator Life Extension Device
• 04250273750164 - Volumat™ Line: 2024-03-29 IV administration set for infusion pumps
• 04250273750218 - Volumat™ Line: 2024-03-29 IV administration set for infusion pumps
• 04250273750287 - Volumat™ Line: 2024-03-29 IV administration set for infusion pumps
• 04250273750294 - Volumat™ Line: 2024-03-29 IV administration set for infusion pumps
• 10810020441632 - Amicus Apheresis Kit - Functionally Closed Single Needle with PAS Spike and Dual: 2024-02-01 For Extended Platelet Storage with Plasma and Red Blood Cell Collection. For Platelet Storage in Plasma or Platelet Additive Sol
• 10810020441649 - Amicus Apheresis Kit - Functionally Closed Double Needle with PAS Spike and Dual: 2024-02-01 For Extended Platelet Storage and Plasma Collection. For Platelet Storage in Plasma or Platelet Additive Solution Plus Plasma. F