IVX Station Stock Solution Transfer Set

GUDID 10860007260404

The IVX Station Stock Solution Transfer Set is a single use device indicated for use with the IVX Station Pharmacy Compounding System for aseptic transfer of fluid from an I.V. bag of compounded drug into a final container(s) for use in the preparation of final compounded drugs for patient infusion administration.

Omnicell, Inc.

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• Primary Device ID: 10860007260404
• NIH Device Record Key: b3901fd2-f555-4777-b0b4-54afc758d4bc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: IVX Station Stock Solution Transfer Set
• Version Model Number: IVX Station Stock Solution 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	00860007260407 [Primary]
GS1	10860007260404 [Package]; Contains: 00860007260407; Package: Inner Pack-shelf box [5 Units]; In Commercial Distribution
GS1	20860007260401 [Package]; 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: 2023-06-14
• Device Publish Date: 2023-06-06

Devices Manufactured by Omnicell, Inc.

• 10860007260404 - IVX Station Stock Solution Transfer Set: 2023-06-14The IVX Station Stock Solution Transfer Set is a single use device indicated for use with the IVX Station Pharmacy Compounding System for aseptic transfer of fluid from an I.V. bag of compounded drug into a final container(s) for use in the preparation of final compounded drugs for patient infusion administration.
• 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