FDA-Device2015-07-08Class II
LifeHealth, IRMA TRUPOINT model 443914, typically used in point-of-care settings. For the in vitro measurement of various critical care analytes in human whole blood. These analytes includes: pO2, pCO2, pH, iCa, Na, K and Cl.
LifeHealth, LLC
Hazard
The barometric pressure measurement output of this particular IRMA TRUPoint SN 443914 device will drift over time.
Sold states
Worldwide distribution. US in the state of MI; INDONESIA, UNITED ARAB EMIRATES, LITHUANIA, POLAND, and PERU.
Affected count
7
Manufactured in
2656 Patton Rd, Roseville, MN, United States
Products
LifeHealth, IRMA TRUPOINT model 443914, typically used in point-of-care settings. For the in vitro measurement of various critical care analytes in human whole blood. These analytes includes: pO2, pCO2, pH, iCa, Na, K and Cl.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1919-2015Don't want to check this manually?
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