Amicus MNC Apheresis Kit - Double Needle X6R2326

GUDID 04086000100144

For Mononuclear Cell (MNC) Collection. For use with the AMICUS separator. Sterile Fluid Path.

Fresenius Kabi AG

Apheresis system tubing set

• Primary Device ID: 04086000100144
• NIH Device Record Key: c2acaef4-7581-4891-8e04-a586154d485d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Amicus MNC Apheresis Kit - Double Needle
• Version Model Number: X6R2326
• Catalog Number: X6R2326
• 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. Protect from freezing. Avoid excessive heat.

Device Identifiers

Device Issuing Agency	Device ID
GS1	04086000100144 [Primary]
GS1	14086000100141 [Package]; Package: Carton [6 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• BK000047

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: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-05

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