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The PureBMC SupraPhysiologic Concentrating System is intended to be used in a clinical laboratory or intraoperatively at the point of care for the safe and rapid preparation of platelet concentrate from a small sample of bone marrow aspirate. The safety and effectiveness of this device for in vivo indications for use has not been established.

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The SmartPReP2 Centrifuge System is intended to be used in the clinical laboratory or intraoperatively at point-of-care for the safe and rapid preparation of platelet poor plasma and platelet concentrate from a small sample of blood and for preparation of a cell concentrate from bone marrow. The SmartPReP Centrifuge System is designed to be used in the clinical laboratory or intraoperatively at point-of-care for the safe and rapid preparation of platelet poor plasma and platelet concentrate from a small sample of blood.

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The AXP Platform MarrowXpress System is intended to be used in the clinical laboratory or intraoperatively at the point of care for preparation of a cell concentrate from bone marrow.

The AXP Platform MarrowXpress System is a semi-automated, closed system that harvests a precise, operator-determined volume of stem cell-rich buffy coat from human bone marrow. The system consists of the following major components 1) disposable Processing Bag Set, 2) rechargeable NiMH battery-powered MXP Device, 3) AC-powered Docking Station, and 4) XpressTRAK software. Accessories include a bar code scanner, weight kit, counterweight, and MXP Device stand. The AXP Platform MarrowXpress System is intended to be used in the clinical laboratory or intraoperatively at the point of care for preparation of a cell concentrate from bone marrow. The MXP Device separates the bone marrow aspirate into red blood cells, plasma, and buffy coat utilizing a standard laboratory centrifuge, and meters each of these components into a separate compartment within the disposable Processing Set. The Processing Set is provided sterile with a non-pyrogenic fluid pathway, and is for single use only. After processing, the MXP Device is placed into the AC powered Docking Station. The Docking Station automatically downloads processing data into the XpressTRAK software and recharges the MXP Device battery pack. The following information is communicated to the XpressTRAK software via a serial connection: MXP Device serial number, errors detected during processing, duration of processing, g force during processing, and mass calculation data. The XpressTRAK application software manages and stores the bone marrow processing data, verifies operational status of the system, and has report production capabilities. The software permits the user to search and sort collected data using the following fields: centrifuge ID, bone marrow aspirate unit number, Processing Bag Set lot number, buffy coat volume, user-definable fields, user name, or date and time.

The MarrowStim™ Concentration Kit and the MarrowStim™ Mini Concentration Kit are intended to be used in the clinical laboratory or intraoperatively at point-of-care for the safe and rapid preparation of platelet poor plasma and platelet concentrate from a small sample of blood and for preparation of a cell concentrate from bone marrow.

The MarrowStim™ Concentration Kit and MarrowStim™ Mini Concentration Kit consist of a table-top, swinging bucket centrifuge and accessories to allow for preparation of platelet poor plasma and platelet concentrate from blood, and for preparation of a cell concentrate from bone marrow.

The GenesisCS Component Concentrating System is intended to be used in a clinical laboratory or intraoperatively at the point of care for the safe and rapid preparation of plasma and platelet concentrate from a small sample of blood and for a preparation of a cell concentrate from bone marrow. The safety and effectiveness of this device for in vivo indications for use has not been established.

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The SmartPReP2 Centrifuge System is intended to be used in the clinical laboratory or intraoperatively at point-of-care for the safe and rapid preparation of platelet poor plasma and platelet concentrate from a small sample of blood and for preparation of a cell concentrate from bone marrow.

The Harvest Technologies SmartPReP2 System includes a table-top, self-decanting swinging bucket centrifuge. The SmartPReP2 Bone Marrow Procedure Pack includes a Process Disposable and other accessories to allow for separation of cells from bone marrow aspirate.

The COBE® Angel Whole Blood Separation System is intended to be used at the patient's point-of-care for the safe and rapid preparation of platelet poor plasma and platelet rich plasma from a sample of whole blood. The plasma and concentrated platelets can be used for diagnostic tests.

The COBE® Angel Whole Blood Separation System consists of a blood centrifugation device and associated disposable processing set and whole blood access kit. The device is intended to be used at the patient's point-of-care for the safe and rapid preparation of platelet poor plasma and platelet rich plasma from a sample of whole blood. The Blood Access Kit contains syringes, needles, anticoagulant, and a site preparation kit for collecting the blood to be processed with the Angel System. The Processing Set utilizes a variable volume separation chamber that separates autologous whole blood cells, platelet poor plasma, and platelet rich plasma. The Processing Set is provided sterile with a non-pyrogenic fluid pathway, and is for single patient use only. The Processing Set consists of the pre-connected variable volume separation chamber, a tubing set with a platelet sensor/valve assembly, and a three-compartment reservoir bag to hold the blood products (whole blood, red blood cells, and platelet poor plasma). A syringe is provided to collect the platelet rich plasma. The primary features of the Angel System hardware are the centrifuge well and lid, roller pump, platelet sensor, valve assembly driver, touch screen user interface, and emergency stop switch. The platelet sensor detects the presence of the separated blood components as they exit the variable volume separation chamber, and switches the position of a rotating valve in the Processing Set to channel the individual blood components into their respective collection containers.

The SECQUIRE cell separator is designed for the safe and effective preparation of low volume platelet rich plasma, and platelet poor plasma at the point of care.

SECQUIRE Cell Separator

The AutoloGel Process Centrifuge is designed to be used at the patient's point of care for the safe and rapid preparation of platelet-rich plasma (PRP) from a small sample of the patient's blood (up to 60 ml).

The AutoloGel Process Centrifuge consists of a table-top, non self-decanting, rotor spin centrifuge and processing disposables designed to allow for rapid automatic separation of plasma and red blood cells from a small volume of whole blood. The centrifuge spins at a maximum speed of 7200 rpms producing a maximum force of approximately 4227 g.

The GPS™ Platelet Separation kit is designed for use in the clinical laboratory or intraoperatively at point of care, for the safe and effective preparation of platelet poor plasma and platelet concentrate from a small sample (50-60 ml) of whole blood. The plasma and concentrated platelets can be used for diagnostic tests.

The GPSTM separation kit aids separation of the patient's own blood components by density through the use of the GPS™-Thermo International Equipment Company (IEC) centrifuge. The GPS™ separation kit permits platelet rich plasma to be rapidly prepared from a small volume of the patient's blood that is drawn at the time of treatment. Kit Components: 18 gauge x 1" x 12" apheresis needle, 16 gauge centesis needle 1 1/4" catheter, 60 ml piston syringe, 30 ml piston syringe, 1 ml piston syringe, petri dish, rubber tubing tourniquet, gauze pad, alcohol pad, adhesive tape, silicone tube, volume gauge, PETG tray with sealed Tyvek® lid, 50 ml bottle of anticoagulant citrate dextrose solution, U.S.P., Solution A (ACD-A).