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Devices
ABL90 FLEX Analyzer Radiometer Medical ApS
Model / Serial
Lot R0375N009, Model #393-090, S/N 393-090R0027N001 - 393-090R0379N010
Product Classification
Clinical Chemistry and Clinical Toxicology Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide Distribution - USA including AL, AZ, CA, CO, CT, DC, FL, GA, IA, ID, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NM, NY, OH, OK, OK, OR, PA, SC, TN, TX, UT, VA, VT, WA, WI & WV and Internationally to Australia, Austria, Canada, China, Czech Republic, Denmark, Finland, France, Germany, Hungary, Italy, Japan, Netherlands, Norway, Poland, Russia, Singapore, South Africa, Spain, Sweden, Switzerland, Turkey & United Kingdom.
Product Description
ABL90 FLEX Analyzer Radiometer Medical ApS, ¿kandevej 21 || Br¿nsh¿j, Denmark || A portable, automated analyzer that measures pH, blood gases, electrolytes, glucose, lactate, bilirubin and oximetry in whole blood.
Manufacturer
Radiometer America Inc
1 Event
Recall of ABL90 FLEX Analyzer Radiometer Medical ApS
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Manufacturer
Radiometer America Inc
Manufacturer Address
Radiometer America Inc, 810 Sharon Dr, Westlake OH 44145-1521
Manufacturer Parent Company (2017)
Danaher Corporation
Source
USFDA
Language
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