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The Power Infuser® Model M100B-3A is intended for continuous or intermittent administration of therapeutic and clinically appropriate intravenous fluids, blood and packed red blood cells through clinically acceptable access points. The device is intended for use by medical, paramedical and EMT personnel in the field and in pre-hospital and hospital environments. When used with the Crystalloid/Colloid Cartridge the device is intended to deliver crystalloid and colloid resuscitative fluids. It is not intended to support the infusion of blood or blood products. When used with the Blood Cartridge the device is intended to deliver crystalloid and colloid resuscitative fluids, whole blood and packed red blood. The device is not intended to support the delivery of any pharmaceutical or other medications.

The Power Infuser model M100B-3A, reviewed and cleared under (K030739) is a miniature battery-operated infusion pump designed to deliver IV fluids and blood products to patients in the field, in pre-hospital transport, or in the hospital. When used with the Crystalloid/Colloid Cartridge, the device infuses crystalloid and colloid IV fluids, the most common initial therapy used to restore a patient's blood pressure and intravascular volume in both pre-hospital and hospital settings. When the device is used with the Blood Cartridge, it is intended to deliver crystalloid and colloid resuscitative fluids as well as whole blood and packed red blood cells. The device is not intended to support the delivery of any pharmaceutical or other medications.

General surgical fluid irrigation and infiltration.

The principles of operation and technology incorporated in the 1000 Pressure Infusor are equivalent to pressurized irrigation systems, which use compressed nonflammable gases within a closed bladder (inflatable cuff to apply direct pressure externally to a bag of fluid for infusion of fluids).

The 3600 Pressure Infusor indications for use are general surgical fluid irrigation and infiltration.

The principles of operation and technology incorporated in the 3600 Pressure Infusor are equivalent to pressurized irrigation systems, which use compressed nonflammable gases within a closed bladder (inflatable cuff to apply direct pressure externally to a bag of fluid for infusion of fluids.

The Big Bag 3000 Pressure Infusor indications for use are general surgical fluid irrigation and infiltration.

The principles of operation and technology incorporated in the Big Bag 3000 Pressure Infusor are equivalent to pressurized irrigation systems, which use compressed nonflammable gases within a closed bladder (inflatable cuff) to apply direct pressure externally to a bag of fluid for infusion of fluids.