CompoDock 9028721

GUDID 04086000860215

The CompoDock is used for the production of special cellular blood components, e.g. in blood banks where tube connections are needed that provide prot

Fresenius Kabi AG

Laboratory tubing welder

• Primary Device ID: 04086000860215
• NIH Device Record Key: 6acfbf22-f04b-43a2-9c26-b4ca67900e51
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CompoDock
• Version Model Number: 9028721
• Catalog Number: 9028721
• 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: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +4961726868436
• Email: dieter.fries@fresenius-kabi.co

Device Identifiers

Device Issuing Agency	Device ID
GS1	04086000860215 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• BK040076

FDA Product Code

• KSB: Set, Transfer (Blood/Plasma)

Sterilization

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

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

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• 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