AMICUS Apheresis Kit - Functionally Closed Single Needle with PAS Spike 4R2358

GUDID 10810020440277

For Extended Platelet Storage with Plasma and Red Blood Cell Collection. For Platelet Storage in Plasma or Platelet Additive Solution Plus Plasma. For Use with the AMICUS Separator.

Fresenius Kabi AG

Apheresis system tubing set

• Primary Device ID: 10810020440277
• NIH Device Record Key: 0a50cea9-00d8-4e11-be46-eafc28283918
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AMICUS Apheresis Kit - Functionally Closed Single Needle with PAS Spike
• Version Model Number: 4R2358
• Catalog Number: 4R2358
• 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 *The storage range for this kit is 0°C (32°F) – 40°C (104°F), however it is recommended to be stored at Room Temperature.
• Special Storage Condition, Specify: Between 0 and 0 *The storage range for this kit is 0°C (32°F) – 40°C (104°F), however it is recommended to be stored at Room Temperature.
• Special Storage Condition, Specify: Between 0 and 0 *The storage range for this kit is 0°C (32°F) – 40°C (104°F), however it is recommended to be stored at Room Temperature.
• Special Storage Condition, Specify: Between 0 and 0 *The storage range for this kit is 0°C (32°F) – 40°C (104°F), however it is recommended to be stored at Room Temperature.
• Special Storage Condition, Specify: Between 0 and 0 *The storage range for this kit is 0°C (32°F) – 40°C (104°F), however it is recommended to be stored at Room Temperature.
• Special Storage Condition, Specify: Between 0 and 0 *The storage range for this kit is 0°C (32°F) – 40°C (104°F), however it is recommended to be stored at Room Temperature.
• Special Storage Condition, Specify: Between 0 and 0 *The storage range for this kit is 0°C (32°F) – 40°C (104°F), however it is recommended to be stored at Room Temperature.
• Special Storage Condition, Specify: Between 0 and 0 *The storage range for this kit is 0°C (32°F) – 40°C (104°F), however it is recommended to be stored at Room Temperature.
• Special Storage Condition, Specify: Between 0 and 0 *The storage range for this kit is 0°C (32°F) – 40°C (104°F), however it is recommended to be stored at Room Temperature.
• Special Storage Condition, Specify: Between 0 and 0 *The storage range for this kit is 0°C (32°F) – 40°C (104°F), however it is recommended to be stored at Room Temperature.
• Special Storage Condition, Specify: Between 0 and 0 *The storage range for this kit is 0°C (32°F) – 40°C (104°F), however it is recommended to be stored at Room Temperature.
• Special Storage Condition, Specify: Between 0 and 0 *The storage range for this kit is 0°C (32°F) – 40°C (104°F), however it is recommended to be stored at Room Temperature.
• Special Storage Condition, Specify: Between 0 and 0 *The storage range for this kit is 0°C (32°F) – 40°C (104°F), however it is recommended to be stored at Room Temperature.
• Special Storage Condition, Specify: Between 0 and 0 *The storage range for this kit is 0°C (32°F) – 40°C (104°F), however it is recommended to be stored at Room Temperature.
• Special Storage Condition, Specify: Between 0 and 0 *The storage range for this kit is 0°C (32°F) – 40°C (104°F), however it is recommended to be stored at Room Temperature.
• Special Storage Condition, Specify: Between 0 and 0 *The storage range for this kit is 0°C (32°F) – 40°C (104°F), however it is recommended to be stored at Room Temperature.

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810020440270 [Primary]
GS1	10810020440277 [Package]; Contains: 00810020440270; Package: Carton [6 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• BK230824

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: 2023-05-30
• Device Publish Date: 2023-05-22

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