Ivenix, Inc. LVP-SW-0001

GUDID 00811505030122

Large Volume Pump (LVP) Software (order 1 per pump), version 2.0

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 ID00811505030122
NIH Device Record Key88c48a89-ab6f-46b9-b78c-5bb33321968d
Commercial Distribution StatusIn Commercial Distribution
Brand NameIvenix, Inc.
Version Model Number2.0
Catalog NumberLVP-SW-0001
Company DUNS939332289
Company NameIVENIX, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone978-775-8100
Emailsupport@ivenix.com
Phone978-775-8100
Emailsupport@ivenix.com
Phone978-775-8100
Emailsupport@ivenix.com
Phone978-775-8100
Emailsupport@ivenix.com
Phone978-775-8100
Emailsupport@ivenix.com
Phone978-775-8100
Emailsupport@ivenix.com
Phone978-775-8100
Emailsupport@ivenix.com
Phone978-775-8100
Emailsupport@ivenix.com
Phone978-775-8100
Emailsupport@ivenix.com
Phone978-775-8100
Emailsupport@ivenix.com
Phone978-775-8100
Emailsupport@ivenix.com
Phone978-775-8100
Emailsupport@ivenix.com
Phone978-775-8100
Emailsupport@ivenix.com
Phone978-775-8100
Emailsupport@ivenix.com
Phone978-775-8100
Emailsupport@ivenix.com
Phone978-775-8100
Emailsupport@ivenix.com
Phone978-775-8100
Emailsupport@ivenix.com
Phone978-775-8100
Emailsupport@ivenix.com
Phone978-775-8100
Emailsupport@ivenix.com
Phone978-775-8100
Emailsupport@ivenix.com
Phone978-775-8100
Emailsupport@ivenix.com
Phone978-775-8100
Emailsupport@ivenix.com
Phone978-775-8100
Emailsupport@ivenix.com
Phone978-775-8100
Emailsupport@ivenix.com
Phone978-775-8100
Emailsupport@ivenix.com
Phone978-775-8100
Emailsupport@ivenix.com
Phone978-775-8100
Emailsupport@ivenix.com
Phone978-775-8100
Emailsupport@ivenix.com
Phone978-775-8100
Emailsupport@ivenix.com
Phone978-775-8100
Emailsupport@ivenix.com
Phone978-775-8100
Emailsupport@ivenix.com
Phone978-775-8100
Emailsupport@ivenix.com
Phone978-775-8100
Emailsupport@ivenix.com
Phone978-775-8100
Emailsupport@ivenix.com
Phone978-775-8100
Emailsupport@ivenix.com
Phone978-775-8100
Emailsupport@ivenix.com
Phone978-775-8100
Emailsupport@ivenix.com
Phone978-775-8100
Emailsupport@ivenix.com
Phone978-775-8100
Emailsupport@ivenix.com
Phone978-775-8100
Emailsupport@ivenix.com
Phone978-775-8100
Emailsupport@ivenix.com
Phone978-775-8100
Emailsupport@ivenix.com
Phone978-775-8100
Emailsupport@ivenix.com
Phone978-775-8100
Emailsupport@ivenix.com
Phone978-775-8100
Emailsupport@ivenix.com
Phone978-775-8100
Emailsupport@ivenix.com
Phone978-775-8100
Emailsupport@ivenix.com
Phone978-775-8100
Emailsupport@ivenix.com
Phone978-775-8100
Emailsupport@ivenix.com
Phone978-775-8100
Emailsupport@ivenix.com
Phone978-775-8100
Emailsupport@ivenix.com
Phone978-775-8100
Emailsupport@ivenix.com
Phone978-775-8100
Emailsupport@ivenix.com
Phone978-775-8100
Emailsupport@ivenix.com
Phone978-775-8100
Emailsupport@ivenix.com
Phone978-775-8100
Emailsupport@fresenius-kabi.com
Phone978-775-8100
Emailsupport@fresenius-kabi.com
Phone978-775-8100
Emailsupport@fresenius-kabi.com
Phone978-775-8100
Emailsupport@fresenius-kabi.com
Phone978-775-8100
Emailsupport@fresenius-kabi.com
Phone978-775-8100
Emailsupport@fresenius-kabi.com
Phone978-775-8100
Emailsupport@fresenius-kabi.com
Phone978-775-8100
Emailsupport@fresenius-kabi.com
Phone978-775-8100
Emailsupport@fresenius-kabi.com
Phone978-775-8100
Emailsupport@fresenius-kabi.com
Phone978-775-8100
Emailsupport@fresenius-kabi.com
Phone978-775-8100
Emailsupport@fresenius-kabi.com
Phone978-775-8100
Emailsupport@fresenius-kabi.com
Phone978-775-8100
Emailsupport@fresenius-kabi.com
Phone978-775-8100
Emailsupport@fresenius-kabi.com
Phone978-775-8100
Emailsupport@fresenius-kabi.com
Phone978-775-8100
Emailsupport@fresenius-kabi.com
Phone978-775-8100
Emailsupport@fresenius-kabi.com
Phone978-775-8100
Emailsupport@fresenius-kabi.com
Phone978-775-8100
Emailsupport@fresenius-kabi.com
Phone978-775-8100
Emailsupport@fresenius-kabi.com
Phone978-775-8100
Emailsupport@fresenius-kabi.com
Phone978-775-8100
Emailsupport@fresenius-kabi.com
Phone978-775-8100
Emailsupport@fresenius-kabi.com
Phone978-775-8100
Emailsupport@fresenius-kabi.com
Phone978-775-8100
Emailsupport@fresenius-kabi.com
Phone978-775-8100
Emailsupport@fresenius-kabi.com
Phone978-775-8100
Emailsupport@fresenius-kabi.com
Phone978-775-8100
Emailsupport@fresenius-kabi.com
Phone978-775-8100
Emailsupport@fresenius-kabi.com
Phone978-775-8100
Emailsupport@fresenius-kabi.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100811505030122 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FRNPump, Infusion

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-08-14
Device Publish Date2020-08-06

On-Brand Devices [Ivenix, Inc.]

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

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