FDA.reportPublic FDA data

IVX Cloud

Primary DI
00860006285036
Brand
IVX Cloud
Company
Omnicell, Inc.
Model
IVX Cloud
Device description
The IVX Cloud (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 Cloud 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.
Published
2024-01-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
NEPSystem/Device, Pharmacy Compounding

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NEPSystem/Device, Pharmacy CompoundingGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860006285029PreviousGS10
00860006285036PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860006285029008600062850298600062850290860006285029
00860006285036008600062850368600062850360860006285036

GMDN Terms#

Term, Definition table
TermDefinition
Intravenous solution compounderA device that is typically exclusively used in the clinical pharmacy or a manufacturing plant for the production of intravenous (IV) fluids. These fluids will typically be distributed using the appropriate containers.

Regulatory Flags#

DUNS number
080720061
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860007260421IVX Station Reconstitution Transfer SetIVX Station Reconstitution Transfer Set2025-01-23
00860006285043IVX ManagerIVX Manager2024-05-10
00860006285029IVX CloudIVX Cloud2021-06-25
00860007260407IVX Station Stock Solution Transfer SetIVX Station Stock Solution Transfer Set2023-06-06
10860007260404IVX Station Stock Solution Transfer SetIVX Station Stock Solution Transfer Set2023-06-06
00860006285012XT Anesthesia Workstation (AWS)XT-AWS2021-02-15
00860006285005IVX StationIVX Station2021-02-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00887709166288ICU Medical, Inc.ICU MEDICAL, INC.NEP2026-04-16
00887709166295ICU Medical, Inc.ICU MEDICAL, INC.NEP2026-04-16
00887709166318ICU Medical, Inc.ICU MEDICAL, INC.NEP2026-04-16
00887709170988ICU Medical, Inc.ICU MEDICAL, INC.NEP2026-04-16
00887709127371ICU Medical, Inc.ICU MEDICAL, INC.NEP2026-04-01
00887709127388ICU Medical, Inc.ICU MEDICAL, INC.NEP2026-04-01
00887709127395ICU Medical, Inc.ICU MEDICAL, INC.NEP2026-04-01
00887709127432ICU Medical, IncICU MEDICAL, INC.NEP2026-04-01
00887709125995ICU Medical, Inc.ICU MEDICAL, INC.NEP2026-01-12
00887709167216ICU Medical, Inc.ICU MEDICAL, INC.NEP2025-10-20
00860001977356OnsetOnpharma CompanyNEP2025-09-19
00085412169286DUO-VENTBaxter Healthcare SANEP2025-03-20
50085412169281DUO-VENTBaxter Healthcare SANEP2025-03-20
00860006285043IVX ManagerOmnicell, Inc.NEP2024-05-10
00840619054908DianaTM Automated Drug Compounding SystemICU MEDICAL, INC.NEP2024-02-20
00840619065058DianaTM Automated Drug Compounding SystemICU MEDICAL, INC.NEP2024-02-20
00840619089894DianaTM Automated Drug Compounding SystemICU MEDICAL, INC.NEP2024-02-20
00840619090876DianaTM Automated Drug Compounding SystemICU MEDICAL, INC.NEP2024-02-20
00840619091590DianaTM Automated Drug Compounding SystemICU MEDICAL, INC.NEP2024-02-20
00850033629408Acta MedicalActa Medical LLCNEP2024-02-14
08426314948258GRI-FILLLABORATORIOS GRIFOLS SANEP2023-07-19
00887709125117DianaTM Compounding Workflow SystemICU MEDICAL, INC.NEP2023-04-10
00887709125124DianaTM Compounding Workflow SystemICU MEDICAL, INC.NEP2023-04-10
00887709125131DianaTM Compounding Workflow SystemICU MEDICAL, INC.NEP2023-04-10
00887709125735DianaTM Compounding Workflow SystemICU MEDICAL, INC.NEP2023-04-10
00887709126497DianaTM Compounding Workflow SystemICU MEDICAL, INC.NEP2023-04-10
00887709126589DianaTM Compounding Workflow SystemICU MEDICAL, INC.NEP2023-04-10
00887709126596DianaTM Compounding Workflow SystemICU MEDICAL, INC.NEP2023-04-10
00887709126749DianaTM Compounding Workflow SystemICU MEDICAL, INC.NEP2023-04-10
00887709126770DianaTM Compounding Workflow SystemICU MEDICAL, INC.NEP2023-04-10