IVX Station

GUDID 00860006285005

The Omnicell IVX Station is intended for use in the automated preparation of pharmaceutical admixtures and syringes consisting of Non-hazardous drugs and diluents, or, Hazardous drugs compounded in non-hazardous Primary Engineering Controls (PECs) as a result of site-specific hazard risk analysis, to be used for intravenous administration.

Omnicell, Inc.

Intravenous solution compounder

• Primary Device ID: 00860006285005
• NIH Device Record Key: 495fb1b4-8819-42fe-baa1-f501670bb912
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: IVX Station
• Version Model Number: IVX Station
• Company DUNS: 080720061
• Company Name: Omnicell, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860006285005 [Primary]

FDA Product Code

• NEP: System/Device, Pharmacy Compounding

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: 2021-02-16
• Device Publish Date: 2021-02-08

Devices Manufactured by Omnicell, Inc.

• 00860006285043 - IVX Manager: 2024-05-20 The IVX Manager (system) manages the administration, setup, and medication workflows for pharmacy IV devices, including tracking
• 10860007260404 - IVX Station Stock Solution Transfer Set: 2023-06-14 The IVX Station Stock Solution Transfer Set is a single use device indicated for use with the IVX Station Pharmacy Compounding S
• 00860006285029 - IVX Cloud: 2021-07-05 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 Station: 2021-02-16The Omnicell IVX Station is intended for use in the automated preparation of pharmaceutical admixtures and syringes consisting of Non-hazardous drugs and diluents, or, Hazardous drugs compounded in non-hazardous Primary Engineering Controls (PECs) as a result of site-specific hazard risk analysis, to be used for intravenous administration.
• 00860006285005 - IVX Station: 2021-02-16 The Omnicell IVX Station is intended for use in the automated preparation of pharmaceutical admixtures and syringes consisting o