FDA-Device2016-08-31Class III
Siemens RAPIDPoint¿ 500 v2.2.2A Software Upgrade Kit; SMN 11066719, Software Version 2.2A The RAPIDPoint 500 system is designed for professional use in a point-of care or laboratory environment. This system tests blood gases, electrolytes, metabolites, total hemoglobin, and hemoglobin derivatives in arterial, venous, and capillary whole blood samples. The following parameters are tested: pH, pC02, p02, Na+, K+, Ca++, Cl-, glucose, lactate, tHb, F02Hb, FCOHb, FMetHb, FHHb, nBili
Siemens Healthcare Diagnostics Inc
Hazard
Some v2.2.2 upgrade kits include a dialysate mode which not cleared/approved for shipment in the United States
Sold states
Nationwide Distribution to AL, CA, MA, NJ, OH, TX, WA, PA
Affected count
76
Manufactured in
2 Edgewater Dr, Norwood, MA, United States
Products
Siemens RAPIDPoint¿ 500 v2.2.2A Software Upgrade Kit; SMN 11066719, Software Version 2.2A The RAPIDPoint 500 system is designed for professional use in a point-of care or laboratory environment. This system tests blood gases, electrolytes, metabolites, total hemoglobin, and hemoglobin derivatives in arterial, venous, and capillary whole blood samples. The following parameters are tested: pH, pC02, p02, Na+, K+, Ca++, Cl-, glucose, lactate, tHb, F02Hb, FCOHb, FMetHb, FHHb, nBili
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2601-2016Don't want to check this manually?
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