Ivenix, Inc. IMS-0500

GUDID 00811505030016

Infusion Management System (IMS), version 2.0

IVENIX, INC.

Infusion pump medication-dosage application software
Primary Device ID00811505030016
NIH Device Record Keyc82a92b8-f4ed-4a87-a093-32d9a94f28dc
Commercial Distribution StatusIn Commercial Distribution
Brand NameIvenix, Inc.
Version Model Number2.0
Catalog NumberIMS-0500
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@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
GS100811505030016 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

PHCInfusion Safety Management Software

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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