FDA-Device2015-02-11Class II
Fresenius Crit Line in a Clip (CLiC) with SW version 2.51 Model Number: CL10041001. A continuous real-time monitor for non-invasive hematocrit, oxygen saturation and percent change in blood volume calculation during hemodialysis treatment.
Fresenius Medical Care Holdings, Inc.
Hazard
Potential for misinterpretation of the graphic display of the Blood Volume ( BV) slope
Sold states
CT, NY
Affected count
35 units
Manufactured in
920 Winter St, N/A, Waltham, MA, United States
Products
Fresenius Crit Line in a Clip (CLiC) with SW version 2.51 Model Number: CL10041001. A continuous real-time monitor for non-invasive hematocrit, oxygen saturation and percent change in blood volume calculation during hemodialysis treatment.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1047-2015Don't want to check this manually?
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