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The Biowy Tym Tube products are indicated for where chronic Eustachian tube dysfunction does not respond to conventional therapy.

The tympanostomy tube is a silicone tube that is intended to provide ventilation and drainage to the middle ear.

The Biowy PICC catheter S Kit is indicated for short or long term peripheral access to the central venous system for intravenous therapy and power injection of contrast media. For blood sampling, infusion or therapy, use 4 French or larger catheter. The maximum recommended infusion rate is 5ml/sec for power injection of contrast media. The maximum pressure of power injectors used with the Biowy catheter may not exceed 300psi. The catheter is available in a kit configuration.

The Biowy PICC catheters are opened-ended radiopaque polyurethane catheters. The catheters are sterile and for single use. They are available in 4F single lumen with 55cm usable length and 5F dual lumen with 60cm usable length. The catheters have a reverse taper design. Catheter shaft is marked with depth indicators, with "0" indicated to serve as a reference for the catheter taper point. Catheters are provided sterile in radiology and nursing configurations for single use. Colorants were added to the catheter shaft and hub to differentiate components. The extension leg, junction and clamp were printed with markings to identify the catheter and to include information to facilitate proper use of the device. The Catheter is provided in a kit with multiple components that includes a stylet, torque adapter and T-lock to facilitate catheter insertion and flushing which are subject to this submission. The stylet has a torque adapter at the end to facilitate handling and withdrawal of the stylet. The catheter and other components in the kit are unchanged from the predicate device.

The Biowy PICC catheter is indicated for short or long term peripheral access to the central venous system for intravenous therapy and power injection of contrast media. For blood sampling, infusion or therapy, use 4 French or larger catheter. The maximum recommended infusion rate is 5ml/sec for power injection of contrast media. The maximum pressure of power injectors used with the Biowy catheter may not exceed 300psi.

The Biowy PICC catheters are opened-ended radiopaque polyurethane catheters are sterile and for single use. They are available in 4F single lumen with 55cm usable length and 5F dual lumen with 60cm usable length. The catheters have a reverse taper design. Catheter shaft is marked with depth indicators, with "0" indicated to serve as a reference for the catheter taper point. Catheters are provided sterile in radiology and nursing configurations for single use. Colorants were added to the catheter shaft and hub to differentiate components. The extension leg, junction and clamp were printed with markings to identify the catheter and to include information to facilitate proper use of the device.