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CAPIOX ® FX – Air Handling

Test conditions:

Bovine blood, Hct 25±1%, Temp. 37±1° C

4.5 L/min blood flow & 7 L/min

100 mL/min air for 1min, EDAC bubble counter

Product Air Removal 4.5 L/min Air Removal 7.0 L/min

FX25 97% 97%

RX25 & AF125 99% 97%

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Children's Hospital at Saint Francis Tulsa OK ... - Perfusion.com

CAPIOX ® FX – Air Handling Test conditions: Bovine blood, Hct 25±1%, Temp. 37±1° C 4.5 L/min blood flow & 7 L/min 100 mL/min air for 1min, EDAC bubble counter Product Air Removal 4.5 L/min Air Removal 7.0 L/min FX25 97% 97% RX25 & AF125 99% 97%

Product design process for FX Oxygenator Phase 4 Scale up/Launch: Final customer checks, regulatory clearance • Confirm product design, packaging. • Validate design requirements through in vitro testing – GME removal, oxygen transfer testing, etc • FDA clearance • Commercialize

Page 1 and 2: The Role of the Manufacturer, Techn
Page 3 and 4: The “Demonstrated Need” Blood m
Page 5 and 6: We Are Getting There….Through Inc
Page 7 and 8: CAPIOX ® FX - Principle of Air Rem
Page 9 and 10: Product design process for FX Oxyge
Page 11 and 12: Hatteland Bubble Counter
Page 13 and 14: EDAC Quantifier
Page 15: Test Protocol Blood Bovine Hematocr
Page 19: Summary • Product development is

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