Clinical Investigation to Evaluate the Hemanext® Oxygen Reduction System - Pivotal Trial

Inclusion Criteria: * Study donor must be ≥ 18 years of age. * Study donor must be ≥ 110 pounds. * Study donor's body temperature must be ≤ 37.5°C / 99.5°F (oral). * Study donor's hemoglobin must be ≥12.5 g/dL if female and ≥13.0 g/dL if male. * Study donor's hematocrit must be ≥ 38% if female and ≥39% if male.Study participants must meet EITHER hemoglobin or hematocrit criteria. * Study donor must meet all criteria per respective site's Research Blood Donation Record (BDR). * Study donor's most recent single RBC unit donation must have been ≥56 days prior to study donation. * Study donor's most recent double RBC unit donation must have been ≥ 112 days prior to study donation. * Study donor must have consented to study participation by reviewing and having expressed understanding the site-respective IRB-approved informed consent form prior to undergoing any study related procedures. 21 CFR 50 * Study donor's testing results from collected blood does not indicate a risk of transfusion-transmitted disease (TTD)\*. * Study donors must agree to report adverse events from the time of signing the informed consent to twenty-four hours following the end of their active study involvement. * Female study donors must not be pregnant, expected to be pregnant or breastfeeding. * Female donors who participate in the in vivo portion of the study: Women of child-bearing age must not be pregnant as determined by a negative pregnancy test prior to each re-infusion. If acceptable by local procedures, post-menopausal or surgically sterile women may be exempt from the pregnancy testing requirement. Exclusion Criteria: * Study donor is \< 18 years of age. * Study donor \< 110 pounds. * Study donor's body temperature is \> 37.5°C / 99.5°F (oral). * Study donor's hemoglobin is \< 12.5 g/dL if female and \< 13.0 g/dL if male. * Study donor's hematocrit is \< 38% if female and \< 39% if male. * Study donor does not meet all criteria per respective site's Research Blood Donation Record (BDR). * Study donor's most recent single RBC unit donation was \< 56 days prior to study donation. * Study donor's most recent double RBC unit donation was \< 112 days prior to study donation. * Study donor has not consented to study participation. * Study donor's testing results from collected blood does indicate a risk of transfusion-transmitted disease (TTD)\*. * Female donors who participate in the in vivo portion of the study: study donor is pregnant, expected to be pregnant or breastfeeding.