Ivenix, Inc. SET-0014-1

GUDID 20811505030034

LVP Blood Products Administration Set, Dual-Inlet, Low-Sorbing, Y-Site, Mesh Filter (Qty 1)

IVENIX, INC.

Electric infusion pump administration set, single-use Electric infusion pump administration set, single-use Electric infusion pump administration set, single-use Electric infusion pump administration set, single-use Electric infusion pump administration set, single-use Electric infusion pump administration set, single-use Electric infusion pump administration set, single-use Electric infusion pump administration set, single-use Electric infusion pump administration set, single-use Electric infusion pump administration set, single-use Electric infusion pump administration set, single-use Electric infusion pump administration set, single-use Electric infusion pump administration set, single-use Electric infusion pump administration set, single-use Electric infusion pump administration set, single-use Electric infusion pump administration set, single-use Electric infusion pump administration set, single-use Electric infusion pump administration set, single-use Electric infusion pump administration set, single-use Electric infusion pump administration set, single-use Electric infusion pump administration set, single-use Electric infusion pump administration set, single-use Electric infusion pump administration set, single-use Electric infusion pump administration set, single-use Electric infusion pump administration set, single-use Electric infusion pump administration set, single-use Electric infusion pump administration set, single-use Electric infusion pump administration set, single-use Electric infusion pump administration set, single-use Electric infusion pump administration set, single-use Electric infusion pump administration set, single-use Electric infusion pump administration set, single-use Electric infusion pump administration set, single-use Electric infusion pump administration set, single-use Electric infusion pump administration set, single-use Electric infusion pump administration set, single-use Electric infusion pump administration set, single-use Electric infusion pump administration set, single-use Electric infusion pump administration set, single-use Electric infusion pump administration set, single-use Electric infusion pump administration set, single-use Electric infusion pump administration set, single-use Electric infusion pump administration set, single-use Electric infusion pump administration set, single-use Electric infusion pump administration set, single-use Electric infusion pump administration set, single-use Electric infusion pump administration set, single-use Electric infusion pump administration set, single-use Electric infusion pump administration set, single-use Electric infusion pump administration set, single-use Electric infusion pump administration set, single-use Electric infusion pump administration set, single-use Electric infusion pump administration set, single-use Electric infusion pump administration set, single-use Electric infusion pump administration set, single-use Electric infusion pump administration set, single-use Electric infusion pump administration set, single-use Electric infusion pump administration set, single-use Electric infusion pump administration set, single-use

• Primary Device ID: 20811505030034
• NIH Device Record Key: 485cdc84-5436-4b3c-810a-eb64d3835251
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ivenix, Inc.
• Version Model Number: SET-0014-1
• Catalog Number: SET-0014-1
• 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@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	00811505030030 [Primary]
GS1	20811505030034 [Package]; Contains: 00811505030030; Package: Shipper [20 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: 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