Ivenix Infusion System SET-0032-01

GUDID 10811505030211

LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Dual Y-Site (Qty 1)

IVENIX, INC.

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• Primary Device ID: 10811505030211
• NIH Device Record Key: e80371e1-d0b2-46f5-bd5d-cd9f0fe355a2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ivenix Infusion System
• Version Model Number: SET-0032-01
• Catalog Number: SET-0032-01
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• 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@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	00811505030214 [Primary]
GS1	10811505030211 [Package]; Contains: 00811505030214; Package: Shipper [25 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K183311

FDA Product Code

• FPA: Set, Administration, Intravascular

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-04-01
• Device Publish Date: 2022-03-24

On-Brand Devices [Ivenix Infusion System]

• 00811505030184: Large Volume Pump (LVP) Software (order 1 per pump), Version 3.0.0
• 00811505030177: Infusion Management System (IMS) Version 3.0.0
• 10811505030235: LVP Primary Administration Set, Single-Inlet, Low-Sorbing, Microbore (Qty 1)
• 10811505030228: LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Dual Y-Site, Microbor
• 10811505030211: LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Dual Y-Site (Qty 1)
• 00811505030351: Infusion Management System (IMS), version 4.0.0
• 00811505030344: Large Volume Pump (LVP) Software (order 1 per pump), version 5.0.0
• 00811505030320: Large Volume Pump (LVP)
• 00811050530399: Infusion Management System (IMS)
• 00811050530375: Large Volume Pump (LVP) Software (order 1 per pump)
• 00811505030399: Infusion Management System (IMS)
• 00811505030375: Large Volume Pump (LVP) Software (order 1 per pump)
• 00811505030443: Infusion Management System (IMS)
• 00811505030436: Large Volume Pump (LVP) Software (order 1 per pump)