IVX Fluid Transfer Set

Set, I.v. Fluid Transfer

Omnicell, Inc.

The following data is part of a premarket notification filed by Omnicell, Inc. with the FDA for Ivx Fluid Transfer Set.

Pre-market Notification Details

• Device ID: K212530
• 510k Number: K212530
• Device Name: IVX Fluid Transfer Set
• Classification: Set, I.v. Fluid Transfer
• Applicant: Omnicell, Inc. 500 Cranberry Woods Drive Cranberry, PA 16066
• Contact: David Vanella
• Correspondent: David Vanella; Omnicell, Inc. 500 Cranberry Woods Drive Cranberry, PA 16066
• Product Code: LHI
• CFR Regulation Number: 880.5440 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2021-08-11
• Decision Date: 2022-04-24

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
10860007260404	K212530	000