IVX Station Reconstitution Transfer Set

Basic Information

• Brand Name: IVX Station Reconstitution Transfer Set
• Primary DI: 00860007260421
• Version / Model: IVX Station Reconstitution Transfer Set
• Company Name: Omnicell, Inc.
• Labeler DUNS: 080513111
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-01-23
• Public Version: 1
• Public Version Date: 2025-01-31
• Public Version Status: New
• Public Device Record Key: 3b5aadc5-51b9-42fe-9a36-2715c8365b83

Device Description

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.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
LHI	Set, I.V. Fluid Transfer	General Hospital	880.5440	2

GMDN Terms

Code	Name	Definition	Implantable	Status
41646	Compounding transfer set	A collection of sterile items typically used in the clinical pharmacy or a manufacturing plant to provide a sterile fluid path for the compounding (mixing) of different multi-ingredient solutions from multiple source containers into a final suitable container. It is typically available in a variety of configurations (e.g., as a 6-lead or a 9-lead set) and includes, e.g., tubes, connectors, spikes. This device may also be used for intravenous (IV) solution compounding. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00860007260421	GS1
Package	10860007260428	GS1	Inner Pack-Shelf Box	5	In Commercial Distribution
Package	20860007260425	GS1	Case	10	In Commercial Distribution

Premarket Submissions

Submission Number	Supplement Number
K212530	000