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The Avail Sterile Water Filled Syringe is intended to be used to provide a sterile liquid for catheter inflation after insertion.

A sterile, water filled, single patient use syringe designed for catheter inflation only. Not for injection. The syringes are bulk packaged for sale to customers for inclusion in urological kits. The syringes are not marketed or sold as separate devices from urological kits. The intended use of the device is to provide a sterile liquid for Foley catheter inflation after insertion. The syringe cap is removed, the syringe luer tip connects directly to the catheter valve. The sterile water is expressed to inflate the catheter. The syringe is disconnected and discarded after use.

The Avail Sterile, Latex Free, Water Filled Syringe is intended to be used to provide sterile water for catheter inflation after insertion.

The Avail Sterile, Latex Free, Water Filled Syringe is a sterile, single patient use, disposable device that is substantially equivalent to the predicate device and other pre-filled syringes. The device is designed for catheter inflation only and is intended for single patient use as was the predicate device.

The Steri-Lub Lubricating Gel is intended to be used in procedures requiring a sterile product (surgical and urological). The Lubrication Gel is intended to be used to lubricate a body orifice to facilitate entry of a diagnostic or therapeutic device.

The Steri-LubTM Lubrication Gel is a sterile, single patient use, disposable instrument that is substantially equivalent to the predicate device and other pre-filled syringes. All Steri-Lubrication Gel syringes are designed for lubrication of a body orifice to facilitate entry of a diagnostic or therapeutic device only and are intended for single patient use.

The Medtronic MiniMed Paradigm Sof-site infusion sets are indicated for the subcutaneous infusion of medicine, including insulin, from a Medtronic MiniMed infusion pump.

The Medtronic MiniMed Paradigm Sof-site infusion sets, models MMT-359S6, MMT-359M6, MMT-359L6, MMT-359S9, MMT-359M9, and MMT-359L9, are infusion administration sets that connect to a Medtronic MiniMed medication reservoir. The infusion sets attach to the medication reservoir by means of a proprietary connecter. Fluid is administered through multi-layer tubing to an indwelling catheter. The indwelling catheter is introduced into the subcutaneous tissue of the user by means of a removable introducer needle. The introducer needle is housed in a plastic needle hub and protected by a plastic needle guard. The needle guard is removed before insertion. The indwelling catheter is affixed to a plastic base unit. The plastic base unit functions as a site for connection. The adhesive patch is integral to the base and is used to secure the unit to the user.

The Medtronic MiniMed Sof-site infusion sets are indicated for the subcutaneous infusion of medicine, including insulin, from a Medtronic MiniMed infusion pump.

The Medtronic MiniMed Sof-site infusion sets, models MMT-358S6. MMT-358M6. MMT-358L6. MMT-358S9. MMT-358M9. and MMT-358L9, are infusion administration sets that connect to a Medtronic MiniMed medication reservoir. The infusion sets attach to the medication reservoir by means of a female Luer connector. Fluid is administered through multi-layer tubing to an indwelling catheter. The indwelling catheter is introduced into the subcutaneous tissue by means of a removable introducer needle. The introducer needle is housed in a plastic needle hub and protected by a plastic needle guard. The needle guard is removed before insertion. The indwelling catheter is affixed to a plastic base unit. The plastic base unit functions as a site for connection and disconnection. The adhesive patch is integral to the base and is used to secure the unit to the user.