AMICUS Apheresis Kit – Single Needle with Platelet Additive Solution Connector L6R2337

GUDID 14086000100059

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: 14086000100059
• NIH Device Record Key: 9a716b6f-2379-4b36-931d-bc58982bc544
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AMICUS Apheresis Kit – Single Needle with Platelet Additive Solution Connector
• Version Model Number: L6R2337
• Catalog Number: L6R2337
• 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: true
• 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.

Device Identifiers

Device Issuing Agency	Device ID
GS1	04086000100052 [Primary]
GS1	14086000100059 [Package]; Contains: 04086000100052; 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: 2024-11-07
• Device Publish Date: 2024-10-30

On-Brand Devices [AMICUS Apheresis Kit – Single Needle with Platelet Additive Solution Connector]

• 14086000100950: AMICUS Apheresis Kit – Single Needle with Platelet Additive Solution Connector
• 14086000100059: For Collection of Platelets with Optional Plasma and/or Red Blood Cells. For Platelet Storage in