Amicus Double Needle Advanced Kit with Platelet Additive Solution Connector 4R2352

GUDID 10810020440710

For Collection of Platelets with Optional Plasma. For Platelet Storage in Plasma or Platelet Additive Solution Plus Plasma. For Use with the AMICUS Separator.

Fresenius Kabi AG

Apheresis system tubing set Apheresis system tubing set Apheresis system tubing set Apheresis system tubing set Apheresis system tubing set Apheresis system tubing set Apheresis system tubing set Apheresis system tubing set Apheresis system tubing set Apheresis system tubing set Apheresis system tubing set Apheresis system tubing set Apheresis system tubing set Apheresis system tubing set Apheresis system tubing set

• Primary Device ID: 10810020440710
• NIH Device Record Key: e72b5d62-7a3a-4b42-8809-fd26d47d6be5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Amicus Double Needle Advanced Kit with Platelet Additive Solution Connector
• Version Model Number: 4R2352
• Catalog Number: 4R2352
• 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	00810020440713 [Primary]
GS1	10810020440710 [Package]; Contains: 00810020440713; 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

• 00810020440591 - AMICUS Separator Legacy Software: 2024-04-04 Software version for AMICUS Separator Legacy Device
• 00810020440607 - AMICUS Separator Life Extension Software: 2024-04-04 Software version for AMICUS Separator Life Extension Device
• 04250273750164 - Volumat™ Line: 2024-03-29 IV administration set for infusion pumps
• 04250273750218 - Volumat™ Line: 2024-03-29 IV administration set for infusion pumps
• 04250273750287 - Volumat™ Line: 2024-03-29 IV administration set for infusion pumps
• 04250273750294 - Volumat™ Line: 2024-03-29 IV administration set for infusion pumps
• 10810020441632 - Amicus Apheresis Kit - Functionally Closed Single Needle with PAS Spike and Dual: 2024-02-01 For Extended Platelet Storage with Plasma and Red Blood Cell Collection. For Platelet Storage in Plasma or Platelet Additive Sol
• 10810020441649 - Amicus Apheresis Kit - Functionally Closed Double Needle with PAS Spike and Dual: 2024-02-01 For Extended Platelet Storage and Plasma Collection. For Platelet Storage in Plasma or Platelet Additive Solution Plus Plasma. F