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XSTAT P15 is intended to be a hemostatic wound dressing.

XSTAT P15 is a hemostatic device for the control of severe, life-threatening bleeding from junctional wounds in the groin or axilla not amenable to tourniquet application in adults and adolescents.

XSTAT P15 is a hemostatic device for the control of severe, life-threatening bleeding from narrow entrance extremity wounds in the arms or legs in adults and adolescents.

XSTAT P15 is a temporary device for use up to six (6) 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 or narrow entrance extremity wounds, and when definitive care at an emergency care facility cannot be achieved within minutes.

XSTAT P15 is NOT indicated for use in: the thorax; the pleural cavity; the mediastinum; the abdomen; the retroperitoneal space; the sacral space; tissues above the inguinal ligament; or tissues above the clavicle.

The XSTAT P15 is comprised of the following components:

1. Minisponge Pouch (1 pouch per device)
2. Applicator/Plunger
3. Packaging and Labeling

The syringe-style applicator is used to deliver the minisponge pouch into bleeding wounds. Upon contact with blood, the minisponges rapidly expand to fill and pack the wound cavity.

The applicator and plunger are injection-molded from medical-grade polypropylene and packaged in a vacuum-sealed nylon/poly pouch. Each unit is terminally sterilized by gamma radiation (SAL 10⁻⁶). The Instructions for Use (IFU) is printed on or affixed to the packaging.

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