Amicus Single Needle Advanced Kit with Platelet Additive Solution Connector 4R2351

GUDID 10810020440703

For Collection of Platelets with Optional Plasma and/or Red Blood Cells. 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: 10810020440703
• NIH Device Record Key: 9a00a7b6-1f08-4c13-b563-6edc0b20d774
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Amicus Single Needle Advanced Kit with Platelet Additive Solution Connector
• Version Model Number: 4R2351
• Catalog Number: 4R2351
• 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 Controlled Room Temperature. Protect from freezing. Avoid excessive heat.
• Special Storage Condition, Specify: Between 0 and 0 *Store at Controlled Room Temperature. Protect from freezing. Avoid excessive heat.
• Special Storage Condition, Specify: Between 0 and 0 *Store at Controlled Room Temperature. Protect from freezing. Avoid excessive heat.
• Special Storage Condition, Specify: Between 0 and 0 *Store at Controlled Room Temperature. Protect from freezing. Avoid excessive heat.
• Special Storage Condition, Specify: Between 0 and 0 *Store at Controlled Room Temperature. Protect from freezing. Avoid excessive heat.
• Special Storage Condition, Specify: Between 0 and 0 *Store at Controlled Room Temperature. Protect from freezing. Avoid excessive heat.
• Special Storage Condition, Specify: Between 0 and 0 *Store at Controlled Room Temperature. Protect from freezing. Avoid excessive heat.
• Special Storage Condition, Specify: Between 0 and 0 *Store at Controlled Room Temperature. Protect from freezing. Avoid excessive heat.
• Special Storage Condition, Specify: Between 0 and 0 *Store at Controlled Room Temperature. Protect from freezing. Avoid excessive heat.
• Special Storage Condition, Specify: Between 0 and 0 *Store at Controlled Room Temperature. Protect from freezing. Avoid excessive heat.
• Special Storage Condition, Specify: Between 0 and 0 *Store at Controlled Room Temperature. Protect from freezing. Avoid excessive heat.
• Special Storage Condition, Specify: Between 0 and 0 *Store at Controlled Room Temperature. Protect from freezing. Avoid excessive heat.
• Special Storage Condition, Specify: Between 0 and 0 *Store at Controlled Room Temperature. Protect from freezing. Avoid excessive heat.
• Special Storage Condition, Specify: Between 0 and 0 *Store at Controlled Room Temperature. Protect from freezing. Avoid excessive heat.
• Special Storage Condition, Specify: Between 0 and 0 *Store at Controlled Room Temperature. Protect from freezing. Avoid excessive heat.

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810020440706 [Primary]
GS1	10810020440703 [Package]; Contains: 00810020440706; Package: Carton [3 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: 2022-04-19
• Device Publish Date: 2022-04-11

Devices Manufactured by Fresenius Kabi AG

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• 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