XSTAT -Model 12 -Hemostatic Device

Indications for Use

XSTAT is a hemostatic device for the control of severe, life-threatening bleeding from junctional wounds in the groin or axilla and bleeding from narrow entrance extremity wounds in the arms or legs not amenable to tourniquet application in adults and adolescents.XSTAT is a temporary device for use up to four (4) hours until surgical care is acquired. It should only be used for patients at high risk for immediate life-threatening bleeding from, hemodynamically significant (Advanced Trauma Life Support class 3 or 4 hemorrhagic shock), non- compressible junctional wounds, and when definitive care at an emergency care facility cannot be achieved within minutes.XSTAT is NOT indicated for use in: the thorax; the pleural cavity; the mediastinum; the abdomen; the retroperitoneal space; the sacral space above the inguinal ligament; or tissues above the clavicle.The XSTAT device is designated as a “Prescription Only” device, to be used by physicians and/or trained medical professionals only