Sendx Medical Inc

Serial Numbers: all ABL80 FLEX CO-OX analyzers with sofware versions 1.30, 1.31, 1.32, 1.33, and 1.34.

Clinical Chemistry and Clinical Toxicology Devices

2

No

Worldwide Distribution-- US Distribution including the state of Ohio and the countries of Switzerland, Germany, France, Poland, Austria, Italy, Japan, Australia, Denmark, China, Sweden, Norway, Spain, United Kingdom, Netherlands, and Czech Republic.

ABL80 FLEX CO-OX analyzer, model #393-841 (all software versions prior to 1.35). || The ABL80 FLEX CO-OX is a portable, automated analyzer that measures pH, blood gases, electrolytes, glucose and oximetry in whole blood. The ABL80 FLEX CO-OX system is intended for use by trained technologists, nurses, physicians and therapists. It is intended for use in a laboratory environment, near patient or point of care setting

Model Numbers: 393-839 (with 933-082 software) and 393-841 (with 933-132 software) All Serial Numbers

Clinical Chemistry and Clinical Toxicology Devices

2

No

Worldwide Distribution - US Nationwide including the state of OH.

ABL80 FLEX (with FLEX software) and ABL80 FLEX CO-OX (with CO-OX software) - pH Blood Gas and Electrolytes Analyzer System. || Intended Use The ABL80 FLEX (with FLEX software) and ABL80 FLEX CO-OX (with CO-OX software) are portable, automated analyzers that measure pH, blood gases, electrolytes, glucose and oximetry (ABL80 FLEX CO-OX only) in whole blood. The ABL80 FLEX (with FLEX software) and ABL80 FLEX CO-OX (with CO-OX software) analyzer systems are intended for use by trained technologists, nurses, physicians and therapists. They are intended for use in a laboratory environment, near patient or point-of-care setting.

Model number: 393-839 Serial number(s): 304157, 304160 and 304162 to 305414 for ABL80 FLEX analyzers

Clinical Chemistry and Clinical Toxicology Devices

2

No

One US consignee in state of OH. Other consignees are international such as Australia, France, Netherlands, Denmark, China, United Kingdom, Turkey, Switzerland, Japan, India, Poland, Spain, and Germany. Distribution list submitted with supporting doc.s

SenDx Medical Inc || ABL80FLEX || Blood Gas, pH, Electrolyte, and Metabolite System || The ABL80 FLEX is a portable, automated analyzer that measures pH, blood gases, electrolytes, glucose, and hematocrit in whole blood. The ABL80 FLEX system is intended for use by trained technologists, nurses, physicians and therapists. It is intended for use in a laboratory environment, near patient or point-of-care setting.