Rio Vial-to-Bag Drug Reconstitution Device

Set, I.v. Fluid Transfer

ICU Medical

The following data is part of a premarket notification filed by Icu Medical with the FDA for Rio Vial-to-bag Drug Reconstitution Device.

Pre-market Notification Details

• Device ID: K192154
• 510k Number: K192154
• Device Name: Rio Vial-to-Bag Drug Reconstitution Device
• Classification: Set, I.v. Fluid Transfer
• Applicant: ICU Medical 951 Calle Amanecer San Clemente, CA 92673
• Contact: Sheila Antonio
• Correspondent: Sheila Antonio; ICU Medical 951 Calle Amanecer San Clemente, CA 92673
• Product Code: LHI
• CFR Regulation Number: 880.5440 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2019-08-09
• Decision Date: 2020-04-20

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
10887709120591	K192154	000