Ivenix, Inc. IMS-0500

GUDID 00811505030016

Infusion Management System (IMS), version 2.0

IVENIX, INC.

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• Primary Device ID: 00811505030016
• NIH Device Record Key: c82a92b8-f4ed-4a87-a093-32d9a94f28dc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ivenix, Inc.
• Version Model Number: 2.0
• Catalog Number: IMS-0500
• Company DUNS: 939332289
• Company Name: IVENIX, INC.
• 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

Customer Support Contacts

• Phone: 978-775-8100
• Email: support@ivenix.com
• Phone: 978-775-8100
• Email: support@ivenix.com
• Phone: 978-775-8100
• Email: support@ivenix.com
• Phone: 978-775-8100
• Email: support@ivenix.com
• Phone: 978-775-8100
• Email: support@ivenix.com
• Phone: 978-775-8100
• Email: support@ivenix.com
• Phone: 978-775-8100
• Email: support@ivenix.com
• Phone: 978-775-8100
• Email: support@ivenix.com
• Phone: 978-775-8100
• Email: support@ivenix.com
• Phone: 978-775-8100
• Email: support@ivenix.com
• Phone: 978-775-8100
• Email: support@ivenix.com
• Phone: 978-775-8100
• Email: support@ivenix.com
• Phone: 978-775-8100
• Email: support@ivenix.com
• Phone: 978-775-8100
• Email: support@ivenix.com
• Phone: 978-775-8100
• Email: support@ivenix.com
• Phone: 978-775-8100
• Email: support@ivenix.com
• Phone: 978-775-8100
• Email: support@ivenix.com
• Phone: 978-775-8100
• Email: support@ivenix.com
• Phone: 978-775-8100
• Email: support@ivenix.com
• Phone: 978-775-8100
• Email: support@ivenix.com
• Phone: 978-775-8100
• Email: support@ivenix.com
• Phone: 978-775-8100
• Email: support@ivenix.com
• Phone: 978-775-8100
• Email: support@ivenix.com
• Phone: 978-775-8100
• Email: support@ivenix.com
• Phone: 978-775-8100
• Email: support@ivenix.com
• Phone: 978-775-8100
• Email: support@ivenix.com
• Phone: 978-775-8100
• Email: support@ivenix.com
• Phone: 978-775-8100
• Email: support@ivenix.com
• Phone: 978-775-8100
• Email: support@ivenix.com
• Phone: 978-775-8100
• Email: support@ivenix.com
• Phone: 978-775-8100
• Email: support@ivenix.com
• Phone: 978-775-8100
• Email: support@ivenix.com
• Phone: 978-775-8100
• Email: support@ivenix.com
• Phone: 978-775-8100
• Email: support@ivenix.com
• Phone: 978-775-8100
• Email: support@ivenix.com
• Phone: 978-775-8100
• Email: support@ivenix.com
• Phone: 978-775-8100
• Email: support@ivenix.com
• Phone: 978-775-8100
• Email: support@ivenix.com
• Phone: 978-775-8100
• Email: support@ivenix.com
• Phone: 978-775-8100
• Email: support@ivenix.com
• Phone: 978-775-8100
• Email: support@ivenix.com
• Phone: 978-775-8100
• Email: support@ivenix.com
• Phone: 978-775-8100
• Email: support@fresenius-kabi.com
• Phone: 978-775-8100
• Email: support@fresenius-kabi.com
• Phone: 978-775-8100
• Email: support@fresenius-kabi.com
• Phone: 978-775-8100
• Email: support@fresenius-kabi.com
• Phone: 978-775-8100
• Email: support@fresenius-kabi.com
• Phone: 978-775-8100
• Email: support@fresenius-kabi.com
• Phone: 978-775-8100
• Email: support@fresenius-kabi.com
• Phone: 978-775-8100
• Email: support@fresenius-kabi.com
• Phone: 978-775-8100
• Email: support@fresenius-kabi.com
• Phone: 978-775-8100
• Email: support@fresenius-kabi.com
• Phone: 978-775-8100
• Email: support@fresenius-kabi.com
• Phone: 978-775-8100
• Email: support@fresenius-kabi.com
• Phone: 978-775-8100
• Email: support@fresenius-kabi.com
• Phone: 978-775-8100
• Email: support@fresenius-kabi.com
• Phone: 978-775-8100
• Email: support@fresenius-kabi.com
• Phone: 978-775-8100
• Email: support@fresenius-kabi.com
• Phone: 978-775-8100
• Email: support@fresenius-kabi.com
• Phone: 978-775-8100
• Email: support@fresenius-kabi.com
• Phone: 978-775-8100
• Email: support@fresenius-kabi.com
• Phone: 978-775-8100
• Email: support@fresenius-kabi.com
• Phone: 978-775-8100
• Email: support@fresenius-kabi.com
• Phone: 978-775-8100
• Email: support@fresenius-kabi.com
• Phone: 978-775-8100
• Email: support@fresenius-kabi.com
• Phone: 978-775-8100
• Email: support@fresenius-kabi.com
• Phone: 978-775-8100
• Email: support@fresenius-kabi.com
• Phone: 978-775-8100
• Email: support@fresenius-kabi.com
• Phone: 978-775-8100
• Email: support@fresenius-kabi.com
• Phone: 978-775-8100
• Email: support@fresenius-kabi.com
• Phone: 978-775-8100
• Email: support@fresenius-kabi.com
• Phone: 978-775-8100
• Email: support@fresenius-kabi.com
• Phone: 978-775-8100
• Email: support@fresenius-kabi.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00811505030016 [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: 2020-08-14
• Device Publish Date: 2020-08-06

On-Brand Devices [Ivenix, Inc.]

• 20811505030157: LVP Epidural Administration Set, Single-Inlet, Low-Sorbing, Microbore, Luer Connector (Qty 1)
• 00811505030122: Large Volume Pump (LVP) Software (order 1 per pump), version 2.0
• 00811505030108: LVP Primary Administration Set, Single-Inlet, Low-Sorbing (Qty 1)
• 20811505030072: LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Y-Site, Microbore (Qt
• 20811505030058: LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Y-Site (Qty 1)
• 20811505030034: LVP Blood Products Administration Set, Dual-Inlet, Low-Sorbing, Y-Site, Mesh Filter (Qty 1)
• 00811505030023: LVP Charging Bracket
• 00811505030016: Infusion Management System (IMS), version 2.0