AGILIA LINK 8 US Z078135

GUDID 04086000856720

Agilia Link 8 is an accessory to Agilia Infusion System as the stacking rack system intended to power and organize eight Agilia infusion pumps at the patient bedside. The Agilia Infusion System includes the Agilia Infusion Pump, which is a programmable electronic medical system dedicated to administering a pre-determined volume of an infusion product at a programmed rate, in combination with disposables and optional accessories.

Fresenius Kabi AG

Intravenous pole multi-outlet holder

• Primary Device ID: 04086000856720
• NIH Device Record Key: 7f49de6f-6a0b-42ca-b21c-4f6c3b56c4b3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AGILIA LINK 8 US
• Version Model Number: Z078135
• Catalog Number: Z078135
• Company DUNS: 315654579
• Company Name: Fresenius Kabi AG
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: (888) 391-6300
• Email: communications.USA@fresenius-kabi.com
• Phone: (888) 391-6300
• Email: communications.USA@fresenius-kabi.com
• Phone: (888) 391-6300
• Email: communications.USA@fresenius-kabi.com
• Phone: (888) 391-6300
• Email: communications.USA@fresenius-kabi.com
• Phone: (888) 391-6300
• Email: communications.USA@fresenius-kabi.com
• Phone: (888) 391-6300
• Email: communications.USA@fresenius-kabi.com
• Phone: (888) 391-6300
• Email: communications.USA@fresenius-kabi.com
• Phone: (888) 391-6300
• Email: communications.USA@fresenius-kabi.com
• Phone: (888) 391-6300
• Email: communications.USA@fresenius-kabi.com
• Phone: (888) 391-6300
• Email: communications.USA@fresenius-kabi.com
• Phone: (888) 391-6300
• Email: communications.USA@fresenius-kabi.com
• Phone: (888) 391-6300
• Email: communications.USA@fresenius-kabi.com
• Phone: (888) 391-6300
• Email: communications.USA@fresenius-kabi.com
• Phone: (888) 391-6300
• Email: communications.USA@fresenius-kabi.com
• Phone: (888) 391-6300
• Email: communications.USA@fresenius-kabi.com
• Phone: (888) 391-6300
• Email: communications.USA@fresenius-kabi.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	04086000856720 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K210073

FDA Product Code

• MRZ: Accessories, Pump, Infusion

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-10-26
• Device Publish Date: 2022-10-18

Devices Manufactured by Fresenius Kabi AG

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• 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
• 00810020440591 - AMICUS Separator Legacy Software: 2024-04-04 Software version for AMICUS Separator Legacy Device