FDA-Device2026-01-21Class II
Ivenix Infusion System (IIS), LVP Software: LVP-SW-0005.
Fresenius Kabi USA, LLC
Hazard
Emphasizing instructions for LVP duration programming located in the IFU.
Sold states
US Nationwide distribution in the states of CA, CO, FL, GA, ID, IL, MD, MI, MI, MN, MS, NE, NJ, NV, OK, OR, SC, TX, VA, WA, WI, WI.
Affected count
30 units
Manufactured in
50 High St Ste 50, North Andover, MA, United States
Products
Ivenix Infusion System (IIS), LVP Software: LVP-SW-0005.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1048-2026Don't want to check this manually?
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