Ivenix Infusion System IMS

GUDID 00811505030450

Infusion Management System (IMS)

Fresenius Kabi AG

Infusion pump medication-dosage application software

• Primary Device ID: 00811505030450
• NIH Device Record Key: 89495a68-c8f4-4523-ae93-34f22d10b2f8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ivenix Infusion System
• Version Model Number: 030-0027-07
• Catalog Number: IMS
• 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: true
• Serial Number: false
• Manufacturing Date: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00811505030450 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K183311

FDA Product Code

• PHC: Infusion Safety Management Software

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: 2024-12-16
• Device Publish Date: 2024-12-06

On-Brand Devices [Ivenix Infusion System]

• 00811505030467: Large Volume Pump (LVP) Software (order 1 per pump)
• 00811505030450: Infusion Management System (IMS)