Omnicell, Inc.

Address:500 Cranberry Woods Dr.,Cranberry Township,PA,16066,US

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Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

System/Device, Pharmacy Compounding (NEP) (2) Cabinet, Table And Tray, Anesthesia (BRY) (1)

Premarket Exempt

Yes

Clear

IVX Station - 00860006285005 Catalog Number :

Device Description : The Omnicell IVX Station is intended for use in the automated preparation of pha The Omnicell IVX Station is intended for use in the automated preparation of pharmaceutical admixtures and syringes consisting of Non-hazardous drugs and diluents, or, Hazardous drugs compounded in non-hazardous Primary Engineering Controls (PECs) as a result of site-specific hazard risk analysis, to be used for intravenous administration.

Device Class : 2

Duns Number: 080720061

Premarket Exempt : Yes

Product Code : NEP

Prescription Use : No

Device Count : 1

XT Anesthesia Workstation (AWS) - 00860006285012 Catalog Number :

Device Description : The Omnicell XT Anesthesia Workstation (AWS) is an automated dispensing system i The Omnicell XT Anesthesia Workstation (AWS) is an automated dispensing system intended for securing and managing medications used by anesthesia providers and pharmacy staff.

Device Class : 1

Duns Number: 079417702

Premarket Exempt : Yes

Product Code : BRY

Prescription Use : No

Device Count : 1

IVX Cloud - 00860006285029 Catalog Number :

Device Description : The IVX Cloud is intended for use in conjunction with IV Solutions products and The IVX Cloud is intended for use in conjunction with IV Solutions products and acts as a source database and web-based compounding operation service. It is used to manage compounding data and orders and makes the data available to users both locally and remotely.

Device Class : 2

Duns Number: 080720061

Premarket Exempt : Yes

Product Code : NEP

Prescription Use : No

Device Count : 1

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