AGILIA USB CABLE US Z073550

GUDID 04086000852074

The Agilia USB Cable is intended to connect the Agilia pumps from Fresenius Kabi to a computer with Fresenius Kabi maintenance or DERS software.

Fresenius Kabi AG

Electrical-only medical device connection cable, reusable

• Primary Device ID: 04086000852074
• NIH Device Record Key: 9195e981-e903-48aa-9849-8c56156ae5d2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AGILIA USB CABLE US
• Version Model Number: Z073550
• Catalog Number: Z073550
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	04086000852074 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K121613

FDA Product Code

• MRZ: Accessories, Pump, Infusion

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2017-09-29

Devices Manufactured by Fresenius Kabi AG

• 10810020441748 - Adaptive Nomogram Bottle: 2025-03-24 For the collection, storage, and shipment of plasma prior to fractionation. For the collection of blood components. Sterile flui
• 00810020440560 - Aurora Xi: 2025-03-06 Aurora Xi Plasmapheresis System with Software Version 2.1
• 00810020442199 - Aurora Xi: 2025-03-06 Aurora Xi Plasmapheresis System with Software Version 2.0
• 10810020441380 - Plasmalink Bottle 1000 mL with locking luer adapter: 2025-01-23 For the collection of blood components. Sterile Fluid Path
• 10810020440512 - Adaptive Nomogram Transfer Pack: 2024-12-20 For processing and/or storage of blood and blood components. Sterile Fluid Path
• 00811505030450 - Ivenix Infusion System: 2024-12-16 Infusion Management System (IMS)
• 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