Fenwal AMICUS Apheresis Kit - Double Needle Functi 4R2365

GUDID 04086000100984

For Extended Platelet Storage and Plasma Collection. For Use with the AMICUS Separator. Sterile Fluid Path.

Fresenius Kabi AG

Apheresis system tubing set

• Primary Device ID: 04086000100984
• NIH Device Record Key: c599c96f-e101-4929-868b-e93b733e6ee7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Fenwal AMICUS Apheresis Kit - Double Needle Functi
• Version Model Number: 4R2365
• Catalog Number: 4R2365
• 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	04086000100984 [Primary]
GS1	14086000100981 [Package]; Package: Carton [6 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• BK150288

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: 2016-09-09

Devices Manufactured by Fresenius Kabi AG

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• 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