IVX Manager

GUDID 00860006285043

The IVX Manager (system) manages the administration, setup, and medication workflows for pharmacy IV devices, including tracking orders (requests) for preparations, reviewing device requests assigned for compounding, customizing workflows and protocols for the IV Solutions products. The IVX Manager is intended for use in conjunction with IV Solutions products and acts as a source database and web-based compounding operation service. It is used to manage compounding data and orders and makes the data available to users both locally and remotely.

Omnicell, Inc.

Intravenous solution compounder
Primary Device ID00860006285043
NIH Device Record Key51a1b268-931e-469a-aada-4dfc96f57be8
Commercial Distribution StatusIn Commercial Distribution
Brand NameIVX Manager
Version Model NumberIVX Manager
Company DUNS080720061
Company NameOmnicell, Inc.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100860006285043 [Primary]

FDA Product Code

NEPSystem/Device, Pharmacy Compounding

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-05-20
Device Publish Date2024-05-10

Devices Manufactured by Omnicell, Inc.

00860006285043 - IVX Manager2024-05-20The IVX Manager (system) manages the administration, setup, and medication workflows for pharmacy IV devices, including tracking orders (requests) for preparations, reviewing device requests assigned for compounding, customizing workflows and protocols for the IV Solutions products. The IVX Manager is intended for use in conjunction with IV Solutions products and acts as a source database and web-based compounding operation service. It is used to manage compounding data and orders and makes the data available to users both locally and remotely.
00860006285043 - IVX Manager2024-05-20 The IVX Manager (system) manages the administration, setup, and medication workflows for pharmacy IV devices, including tracking
10860007260404 - IVX Station Stock Solution Transfer Set2023-06-14 The IVX Station Stock Solution Transfer Set is a single use device indicated for use with the IVX Station Pharmacy Compounding S
00860006285029 - IVX Cloud2021-07-05 The IVX Cloud is intended for use in conjunction with IV Solutions products and acts as a source database and web-based compound
00860006285012 - XT Anesthesia Workstation (AWS)2021-02-23 The Omnicell XT Anesthesia Workstation (AWS) is an automated dispensing system intended for securing and managing medications us
00860006285005 - IVX Station2021-02-16 The Omnicell IVX Station is intended for use in the automated preparation of pharmaceutical admixtures and syringes consisting o

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