BOUND TREE MEDICAL, LLC 1715-01837-DOD Curaplex

WellSky™ Blood – Emergency Issue 2020 R1 is a Blood Establishment Computer Software (BECS) Accessory that provides the ability to perform an Emergency Issue. WellSky Blood – Emergency Issue provides customized control processes for Emergency Issue management to reduce human error and enhance the ability to assure patient product safety. Functionality is provided for patient identification, support of emergency patient safety protocols, issue blood products under emergency conditions and confirmation scan of correct transfusion slip on correct unit. WellSky™ Blood – Emergency Issue 2020 R1 can be used to emergency issue products on a mobile device and desktop workstation.WellSky™ Blood – Emergency Issue 2020 R1 is not a standalone system. WellSky™ Blood Emergency Issue 2020 depends on HCLL™ Transfusion to obtain patient data, as well as to send unit information, safety data, and regulatory inspection step data back to HCLL™ Transfusion. will communicate bi-directionally through intelligent integration messages to obtain patient information and to update and record the Emergency Issue in HCLL™ Transfusion. HCLL™ Transfusion stores this information in the Transfusion database, exactly now Transfusion processes and stored this data currently. WellSky Blood Emergency Issue does not maintain data.

WellSky Transfusion 2022 is a Blood Establishment Computer Software Product. Other than the packaging material/labeling.There is no hardware or other components included in the final product.WellSky Transfusion 2022 is intended to address allphases of transfusion services activities, and assists transfusion service personnel: • Manipulate and label products • Print ISBT128 blood labels • Perform electronic cross match • Issue blood products under normal and emergency conditions • Receive andtest patient and unit specimens • Interface to blood bank testing instruments (bi-directional) • Interface to blood storage device (bidirectional)WellSky Transfusion 2022 provides customized control processes for transfusion management of all procedures andtesting on products and patients to reduce human error and enhance the ability to assure patient and product safety.

WellSky™ Transfusion 2018 is a Blood Establishment Computer Software Product. Other than the packaging material/labeling, there is no hardware or other components included in the final product. WellSky™ Transfusion 2018 is intended to address all phases of transfusion services activities, and assists transfusion service personnel: • Manipulate and label products• Print ISBT 128 blood labels• Perform electronic cross match• Issue blood products under normal and emergency conditions• Receive and test patient and unit specimens• Interface to blood bank testing instruments (bi-directional)• Interface to blood storage devices (bi-directional)WellSky™ Transfusion 2018 provides customized control processes for transfusion management of all procedures and testing on products and patients to reduce human error and enhance the ability to assure patient and product safety

WellSky Transfusion 2021 is a Blood Establishment Computer Software Product. Other than the packaging material/labeling. There is no hardware or other components included in the final product.WellSky Transfusion 2021 is intended to address all phases of transfusion services activities, and assists transfusion service personnel: • Manipulate and label products• Print ISBT 128 blood labels• Perform electronic cross match• Issue blood products under normal and emergency conditions• Receive and test patient and unit specimens• Interface to blood bank testing instruments (bi-directional)• Interface to blood storage device (bi-directional)WellSky Transfusion 2021 provides customized control processes for transfusion management of all procedures and testing on products and patients to reduce human error and enhance the ability to assure patient and product safety.

The Stat Profile Prime Plus Blood Analyzer is a compact, whole blood critical care analyzer that provides rapid and comprehensive results. It measures blood gases, electrolytes, metabolites, and co-oximetry, delivering 32 calculated results. Featuring maintenance-free, replaceable cartridge technology and patented non-lysing co-oximetry, the analyzer produces a complete test panel in about one minute. It also offers bidirectional connectivity and a powerful onboard data management system for efficient data handling and integration

First Aid Kit Wihout Drug (Content : Adhesive bandages in a variety of different sizes and shapes + Non-adherent sterile Gauze Pad + Cleansing wipe (with alcohol)) This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.

The Test of Variables of Attention (T.O.V.A.) kit contains the hardware and software necessary to install and administer the T.O.V.A. continuous performance test. The T.O.V.A. provides healthcare professionals with objective measurements of attention and inhibitory control. The visual T.O.V.A. aids in the assessment of, and evaluation of treatment for, attention deficits, including attention-deficit/hyperactivity disorder (ADHD). The auditory T.O.V.A. aids in the assessment of attention deficits, including ADHD. T.O.V.A. results should only be interpreted by qualified professionals.

WellSky™ Blood – Emergency Issue 2020 R1 is a Blood Establishment Computer Software (BECS) Accessory that provides the ability to perform an Emergency Issue. WellSky Blood – Emergency Issue provides customized control processes for Emergency Issue management to reduce human error and enhance the ability to assure patient product safety. Functionality is provided for patient identification, support of emergency patient safety protocols, issue blood products under emergency conditions and confirmation scan of correct transfusion slip on correct unit. WellSky™ Blood – Emergency Issue 2020 R1 can be used to emergency issue products on a mobile device and desktop workstation.WellSky™ Blood – Emergency Issue 2020 R1 is not a standalone system. WellSky™ Blood Emergency Issue 2020 depends on HCLL™ Transfusion to obtain patient data, as well as to send unit information, safety data, and regulatory inspection step data back to HCLL™ Transfusion. will communicate bi-directionally through intelligent integration messages to obtain patient information and to update and record the Emergency Issue in HCLL™ Transfusion. HCLL™ Transfusion stores this information in the Transfusion database, exactly now Transfusion processes and stored this data currently. WellSky Blood Emergency Issue does not maintain data.

WellSky Transfusion 2022 is a Blood Establishment Computer Software Product. Other than the packaging material/labeling.There is no hardware or other components included in the final product.WellSky Transfusion 2022 is intended to address allphases of transfusion services activities, and assists transfusion service personnel: • Manipulate and label products • Print ISBT128 blood labels • Perform electronic cross match • Issue blood products under normal and emergency conditions • Receive andtest patient and unit specimens • Interface to blood bank testing instruments (bi-directional) • Interface to blood storage device (bidirectional)WellSky Transfusion 2022 provides customized control processes for transfusion management of all procedures andtesting on products and patients to reduce human error and enhance the ability to assure patient and product safety.

WellSky™ Transfusion 2018 is a Blood Establishment Computer Software Product. Other than the packaging material/labeling, there is no hardware or other components included in the final product. WellSky™ Transfusion 2018 is intended to address all phases of transfusion services activities, and assists transfusion service personnel: • Manipulate and label products• Print ISBT 128 blood labels• Perform electronic cross match• Issue blood products under normal and emergency conditions• Receive and test patient and unit specimens• Interface to blood bank testing instruments (bi-directional)• Interface to blood storage devices (bi-directional)WellSky™ Transfusion 2018 provides customized control processes for transfusion management of all procedures and testing on products and patients to reduce human error and enhance the ability to assure patient and product safety

WellSky Transfusion 2021 is a Blood Establishment Computer Software Product. Other than the packaging material/labeling. There is no hardware or other components included in the final product.WellSky Transfusion 2021 is intended to address all phases of transfusion services activities, and assists transfusion service personnel: • Manipulate and label products• Print ISBT 128 blood labels• Perform electronic cross match• Issue blood products under normal and emergency conditions• Receive and test patient and unit specimens• Interface to blood bank testing instruments (bi-directional)• Interface to blood storage device (bi-directional)WellSky Transfusion 2021 provides customized control processes for transfusion management of all procedures and testing on products and patients to reduce human error and enhance the ability to assure patient and product safety.