Amicus MNC Apheresis Kit - Double Needle X7R2326SB

GUDID 01081002044222

For Mononuclear Cell (MNC) Collection. For use with the Amicus Separator.

Fresenius Kabi AG

Apheresis system tubing set

• Primary Device ID: 01081002044222
• NIH Device Record Key: 2a47f05b-c8b0-4116-9794-3d0f4a22f459
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Amicus MNC Apheresis Kit - Double Needle
• Version Model Number: X7R2326SB
• Catalog Number: X7R2326SB
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• 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 *Store at Room Temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Store at Room Temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Store at Room Temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Store at Room Temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Store at Room Temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Store at Room Temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Store at Room Temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Store at Room Temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Store at Room Temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Store at Room Temperature.

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810020442229 [Primary]
GS1	01081002044222 [Package]; Contains: 00810020442229; Package: Carton [6 Units]; In Commercial Distribution

FDA Product Code

• GKT: Separator, Automated, Blood Cell, Diagnostic

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2026-02-11
• Device Publish Date: 2026-02-03

On-Brand Devices [Amicus MNC Apheresis Kit - Double Needle]

• 04086000100144: For Mononuclear Cell (MNC) Collection. For use with the AMICUS separator. Sterile Fluid Path.
• 01081002044222: For Mononuclear Cell (MNC) Collection. For use with the Amicus Separator.