P1R Plasma Treatment Set 9400414

GUDID 04052682003721

Therapeutic Plasma Treatment (e.g. LDL-apheresis)

Fresenius Kabi AG

Apheresis system tubing set

• Primary Device ID: 04052682003721
• NIH Device Record Key: 1c085a0e-f1fe-4721-b0d4-8223ecfbc3de
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: P1R Plasma Treatment Set
• Version Model Number: 9400414
• Catalog Number: 9400414
• 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

Customer Support Contacts

• Phone: +31591355864
• Email: wilma.hilhorst@fresenius-kabi.

Operating and Storage Conditions

• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	04052682003721 [Primary]
GS1	04052682003738 [Package]; Package: [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K961706

FDA Product Code

• LKN: Separator, Automated, Blood Cell And Plasma, Therapeutic

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-09-03
• Device Publish Date: 2016-09-16

Devices Manufactured by Fresenius Kabi AG

• 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
• 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