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The Indications for Use Statements are as follows: AUTOTRANSFUSION - 1. For the collection of autologuous blood from the patient's pleural cavity or mediastinal area for reinfusion purposes in trauma and post-operative situations CHEST DRAINAGE . - 1. To evacuate air and/or fluid from the chest cavity or mediastinum - To help prevent air and/or fluid from re-accumulating in the chest cavity or 2. mediastinum. - 3. To help re-establish and maintain normal intra-thoracic pressure gradients. - 4. To facilitate complete lung re-expansion to restore normal breathing dynamics. The Pleur-evac® Autotransfusion Bag is indicated as a sterile, single use device used for collection and reinfusion of autologous blood from the thoracic cavity when attached to a Pleur-evac® System. The fluid path is non-pyrogenic.

Teleflex Medical offers a line of Chest Drainage and Autotransfusion Systems. This line includes Chest Drainage units with a variety of suction and seal technologies. The three lines are the Wet Suction/Wet Seal, Dry Suction/Wet Seal, and Dry Suction/Dry Seal technologies. The Dry Suction/Dry Seal are branded the Sahara Series. Each technology of Chest Drainage devices can be coupled with an Autotransfusion (ATS) Bag for reinfusion capability. In addition, there is the S-1150-08LF, Pleur-evac Sahara® Plus Continuous Reinfusion Autotransfusion System that can be reinfused from the Drainage Unit. This submission will cover the Sahara reinfusion unit and the ATS Bags that can be mated with the different technology Chest Drainage Units. The Pleur-evac Sahara® Plus Continuous Reinfusion Autotransfusion System (S-1150-08LF) is provided as a sterile unit intended for single patient use. The fluid path is non-pyrogenic. The Pleur-evac Sahara Plus System is used for the collection and continuous reinfusion of autologous blood. By attaching the Pleur-evac Sahara Autotransfusion Bag (S-100-08LF), the Pleur-evac Sahara Plus System serves as a bag reinfusion system. When autotransfusion is completed, the Pleur-evac Sahara Plus System can serve as a chest drainage collection unit. The Autotransfusion(ATS) Bag is a sterile, non-pyrogenic, single-use, blood collection and reinfusion device intended for the post-surgical, chest-drainage market. The ATS Bag attaches to the appropriate Pleur-evac Chest Drainage System. The S-100-08LF attached to a Sahara branded Pleur-evac® unit and an A-1500-08LF attaches to a standard Pleur-evac® unit.