B Braun Medical, Inc

General Hospital and Personal Use Devices

2

No

Worldwide distribution: USA (nationwide) including states of: AR, CA, FL, GA, IA, IL, KS, KY, LA, MA, MI, MO, NC, NJ, NY, OH, PA, SC, TX, VA, WA, WI, and WV; and country of: Canada.

Outlook ES Safety Infusion System, Model 621-100ES, 621-200ES, 621-300ES, and 621-400ES || B. Braun Medical Inc., 1601 Wallace Drive, Suite 150, Carrollton, TX 75006 || The Outlook ES pump is intended for use with B. Braun Medical Inc., Horizon Pump IV Sets to regulate the flow of primary and secondary fluids when positive pressure is required.

Model No. 621-400ES. Premarket Notifications K011975 and K994375. Device Listings D051037 and D051592.

General Hospital and Personal Use Devices

2

No

Virginia and New York

Outlook 400ES Safety Infusion System, Model Number 621-400ES. For use with B. Braun Medical Inc. Horizon Pump IV Sets

General Hospital and Personal Use Devices

2

No

Nationwide Distribution

Outlook ES pump is intended for use with B. Braun Medical Inc. Horizon Pump IV Sets. Used to regulate the flow of primary and secondary fluids when positive pressure is required. The infusion system is capable of delivering fluid from a negative head height (when the IV fluid container is lower than the pump), and provides clinically accepted volumetric accuracy for all standard IV fluids, including blood, lipid, and Total Parenteral Nutrition (TPN). Model number: 621-300ES, 621-400ES, 621-400ESR. || To deliver a broad range of drugs with use with the B. Braun Medical Inc. Horizon Pump IV Sets.