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The AquaFlate Pre-filled Sterile Water Syringe is intended to be used for inflating a Foley catheter balloon.

The proposed device, AquaFlate Pre-Filled Sterile Water Syringe 10mL (REF 250-400), is a 10mL syringe prefilled with USP purified water and sterilized via gamma irradiation. The syringe consists of a polypropylene barrel and plunger and latex free rubber for both the plunger gasket and syringe tip cap. The AquaFlate Pre-Filled Water Syringe 10mL is intended for inflating an indwelling. urethral Foley catheter balloon. In accordance with CDC Guidelines, healthcare facility protocols, and the Foley catheter manufacturer's instructions for use, prior to catheterization, the syringe cap of the AquaFlate Pre-Filled Sterile Water Syringe 10mL is removed and the luer tip of the syringe is connected to the inflation port of the catheter. Once the catheter is inserted into the bladder, the entire contents of the syringe are dispensed to inflate the catheter balloon to ensure the catheter does not slide out. After balloon inflation, the syringe is disconnected from the catheter inflation port and discarded. The AquaFlate Pre-Filled Sterile Water Syringe 10mL is not intended for injection and is for single use only. The shelf life of the AquaFlate Pre-Filled Sterile Water Syringe 10mL is one (1) year. HR Pharmaceuticals does not intend to market this device with accessories or as part of a system.

Eco Vue® Sterile and Non-Sterile Ultrasound couplants intended to be used on intact skin during noninvasive medical ultrasound procedures to couple sound waves between a patient and the medical imaging electronics. The gels are intended for use in all diagnostic ultrasound procedures which require coupling gel or fluid.

The proposed device, EcoVue® Sterile and Non-Sterile Ultrasound Gels, are nonirritating, non-sensitizing acoustic couplants intended for use as a scanning gel in medical diagnostic ultrasound procedures. The gel is an accessory used to couple sound waves between the patient and the medical imaging electronic transducers during diagnostic ultrasound procedures. Ultrasound gel is a type of conductive medium that enables a tight bond between the skin and the probe or transducer, allowing the waves to transmit directly to the tissues beneath and to the parts that need to be imaged. As such, the gel is formulated to serve as a lubricant and improve the acoustic transmission of sound waves to create the ultrasound image.