Ivenix Inc. LVP-0003

GUDID 00811505030009

Large Volume Pump (LVP)

IVENIX, INC.

General-purpose infusion pump, line-powered General-purpose infusion pump, line-powered General-purpose infusion pump, line-powered General-purpose infusion pump, line-powered General-purpose infusion pump, line-powered General-purpose infusion pump, line-powered General-purpose infusion pump, line-powered General-purpose infusion pump, line-powered General-purpose infusion pump, line-powered General-purpose infusion pump, line-powered General-purpose infusion pump, line-powered General-purpose infusion pump, line-powered General-purpose infusion pump, line-powered General-purpose infusion pump, line-powered General-purpose infusion pump, line-powered General-purpose infusion pump, line-powered General-purpose infusion pump, line-powered General-purpose infusion pump, line-powered General-purpose infusion pump, line-powered General-purpose infusion pump, line-powered General-purpose infusion pump, line-powered General-purpose infusion pump, line-powered General-purpose infusion pump, line-powered General-purpose infusion pump, line-powered General-purpose infusion pump, line-powered General-purpose infusion pump, line-powered General-purpose infusion pump, line-powered General-purpose infusion pump, line-powered Bedside infusion pump Bedside infusion pump Bedside infusion pump Bedside infusion pump Bedside infusion pump Bedside infusion pump, single-channel Bedside infusion pump, single-channel Bedside infusion pump, single-channel Bedside infusion pump, single-channel Bedside infusion pump, single-channel Bedside infusion pump, single-channel Bedside infusion pump, single-channel Bedside infusion pump, single-channel Bedside infusion pump, single-channel Bedside infusion pump, single-channel Bedside infusion pump, single-channel Bedside infusion pump, single-channel Bedside infusion pump, single-channel Bedside infusion pump, single-channel Bedside infusion pump, single-channel Bedside infusion pump, single-channel Bedside infusion pump, single-channel Bedside infusion pump, single-channel Bedside infusion pump, single-channel Bedside infusion pump, single-channel Bedside infusion pump, single-channel Bedside infusion pump, single-channel Bedside infusion pump, single-channel Bedside infusion pump, single-channel Bedside infusion pump, single-channel Bedside infusion pump, single-channel Bedside infusion pump, single-channel Bedside infusion pump, single-channel Bedside infusion pump, single-channel Bedside infusion pump, single-channel Bedside infusion pump, single-channel Bedside infusion pump, single-channel Bedside infusion pump, single-channel Bedside infusion pump, single-channel Bedside infusion pump, single-channel Bedside infusion pump, single-channel Bedside infusion pump, single-channel Bedside infusion pump, single-channel Bedside infusion pump, single-channel Bedside infusion pump, single-channel Bedside infusion pump, single-channel Bedside infusion pump, single-channel Bedside infusion pump, single-channel Bedside infusion pump, single-channel Bedside infusion pump, single-channel Bedside infusion pump, single-channel Bedside infusion pump, single-channel Bedside infusion pump, single-channel Bedside infusion pump, single-channel Bedside infusion pump, single-channel Bedside infusion pump, single-channel Bedside infusion pump, single-channel Bedside infusion pump, single-channel

• Primary Device ID: 00811505030009
• NIH Device Record Key: 47d5800c-5ba1-4c5a-9e4e-ab5ab7f359d5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ivenix Inc.
• Version Model Number: LVP-0003
• Catalog Number: LVP-0003
• Company DUNS: 939332289
• Company Name: IVENIX, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• 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@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	00811505030009 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K183311

FDA Product Code

• FRN: Pump, Infusion

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

Devices Manufactured by IVENIX, INC.

• 00811505030436 - Ivenix Infusion System: 2023-08-15 Large Volume Pump (LVP) Software (order 1 per pump)
• 00811505030443 - Ivenix Infusion System: 2023-08-15 Infusion Management System (IMS)
• 00811505030375 - Ivenix Infusion System: 2023-07-27 Large Volume Pump (LVP) Software (order 1 per pump)
• 00811505030399 - Ivenix Infusion System: 2023-07-27 Infusion Management System (IMS)
• 00811505030160 - Ivenix: 2023-05-12 LVP Epidural Administration Set, Single-Inlet, Low-Sorbing, Microbore, NRFit Connector (Qty 1)
• 00811050530375 - Ivenix Infusion System: 2023-04-17 Large Volume Pump (LVP) Software (order 1 per pump)
• 00811050530399 - Ivenix Infusion System: 2023-04-17 Infusion Management System (IMS)
• 00811505030320 - Ivenix Infusion System: 2022-09-15 Large Volume Pump (LVP)