IVX Station Reconstitution Transfer Set

GUDID 00860007260421

The IVX Station Reconstitution Transfer Set is a single use device indicated for use with the IVX Station Pharmacy Compounding System for aseptic reconstitution of lyophilized drug in vial(s) from an I.V. bag source for use in the preparation of final compounded drugs for patient infusion administration.

Omnicell, Inc.

Compounding transfer set

• Primary Device ID: 00860007260421
• NIH Device Record Key: 3b5aadc5-51b9-42fe-9a36-2715c8365b83
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: IVX Station Reconstitution Transfer Set
• Version Model Number: IVX Station Reconstitution Transfer Set
• Company DUNS: 080513111
• Company Name: Omnicell, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860007260421 [Primary]
GS1	10860007260428 [Package]; Package: Inner Pack-Shelf Box [5 Units]; In Commercial Distribution
GS1	20860007260425 [Package]; Contains: 10860007260428; Package: Case [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K212530

FDA Product Code

• LHI: Set, I.V. Fluid Transfer

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-01-31
• Device Publish Date: 2025-01-23

Devices Manufactured by Omnicell, Inc.

• 00860007260421 - IVX Station Reconstitution Transfer Set: 2025-01-31The IVX Station Reconstitution Transfer Set is a single use device indicated for use with the IVX Station Pharmacy Compounding System for aseptic reconstitution of lyophilized drug in vial(s) from an I.V. bag source for use in the preparation of final compounded drugs for patient infusion administration.
• 00860007260421 - IVX Station Reconstitution Transfer Set: 2025-01-31 The IVX Station Reconstitution Transfer Set is a single use device indicated for use with the IVX Station Pharmacy Compounding S
• 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: 2021-02-16 The Omnicell IVX Station is intended for use in the automated preparation of pharmaceutical admixtures and syringes consisting o