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The intended use of the Simplicity Easy P Soft Infusion Set is to provide a means to for infusion and/or injection of fluids into the body below the surface of the skin when attached to a MiniMed Paradigm pump or syringe.

Sterling Medivations Inc.'s ("SMI") Simplicity Easy P Soft designed for use by people with diabetes for the infusion and/or injection of fluids into the body below the surface of the skin when attached to a MiniMed Paradigm pump or syringe. It is inserted into the tissue of a patient and the catheter is attached to the infusion device. It is substantially equivalent to the Simplicity ™ Easy Soft Infusion Set, K020912 and Soft YP Infusion Set, FDA 510 (k) K011187. The Simplicity Easy P Soft Infusion Set proposed for commercial distribution is similar in all significant respects to the existing Simplicity Easy Soft Infusion Set, FDA 510 (k) K020912 and it has the same intended use. The device consists of four main parts: (1) infusion catheters made from Polytetrafluoroethylene (PTFE), (2) an infusion hub that provides the patient the capability of disconnecting tube from the infusion catheter, (3) a connecting tube and (4) a threaded YP connector. The Simplicity Easy P Soft Infusion Set is an infusion administration set, connecting to a medicine reservoir or syringe that is placed in an external infusion device and inserted below the surface of the skin of a patient. The SMI Simplicity Easy Soft Infusion Set may be used with any Paradigm infusion device that delivers continuous or intermittent flow. The administration set attaches to the reservoir/syringe by means of a threaded YP connector, and under the surface of the skin in the patient through an indwelling cannulas formed from PTFE. The connecting tubing is made from a polyethylene tube. The indwelling cannulas formed from PTFE are introduced below the skin using and insertion ring with AISI 304 stainless steel needle is attached to the hub fixed to the indwelling catheter. This seal on the connector needle mates with the indwelling catheter hub that forms a seal that permits the infusion of medication without leakage. The connector needle is made from AISI 304 stainless steel and it is comected to the connecting tubing. The connector tubing proximal end is attached to a threaded YP connector for attachment to the Paradigm medicine reservoir.

The intended use of the Simplicity Easy Access P Infusion Set is to provide a means for infusion and/or injection of fluids into the body below the surface of the skin when attached to a MiniMed Paradigm pump or syringe.

Sterling Medivations Inc.'s ("SMI") Simplicity Easy Access P designed for use by people with diabetes for the infusion and/or injection of fluids into the body below the surface of the skin when attached to a MiniMed Paradigm pump or syringe. It is inserted into thssue of a patient and the catheter is attached to the infusion device. It is substantially equivalent to the Simplicity ™ Easy Access Infusion Set, K014062 and Soft YP Infusion Set, FDA 510 (k) K011187. The Simplicity Easy Access P Infusion Set proposed for commercial distribution is similar in all significant respects to the existing Simplicity Easy Access Infusion Set, FDA 510 (k) K014062 and it has the same intended use. The device consists of four main parts: (1) infusion catheters made from AISI 304 stainless steel, (2) an infusion hub that provides the patient the capability of disconnecting tube from the infusion catheter, (3) a connecting tube and (4) a threaded YP connector. The Simplicity Easy Access P Infusion Set is an infusion administration set, connecting to a medicine reservoir or syringe that is placed in an external infusion device and inserted below the surface of the skin of a patient. The SMI Simplicity Easy Access Infusion Set may be used with any Paradigm infusion device that delivers continuous or intermittent flow. The administration set attaches to the reservoir/syringe by means of a threaded YP connector, and under the surface of the skin in the patient through an indwelling needles formed from AISI 304 stainless steel. The connecting tubing is made from a polyethylene tube. The indwelling needles formed from AISI 304 stainless steel are introduced below the surface of the skin. The connector needle is attached to the indwelling catheter. This seal on the connector needle mates with the indwelling catheter hub that forms a seal that permits the infusion of medication without leakage. The connector needle is made from AISI 304 stainless steel and it is connecting tubing. The connector tubing proximal end is attached to a threaded YP connector for attachment to the Paradigm medicine reservoir.

The intended use of the Simplicity QD Easy P Infusion Set is to provide a means for infusion and/or injection of fluids into the body below the surface of the skin when attached to a MiniMed Paradigm pump or syringe.

Sterling Medivations Inc.'s ("SMI") Simplicity™ QD Easy P Infusion Set is designed to provide a means for infusion and/or injection of fluids into the body below the surface of the skin when attached to the MiniMed Paradigm infusion pump or syringe. The Simplicity QD Easy P Infusion Set is designed for use by people with diabetes to provide a means to infuse or inject medication subcutaneously when attached to the MiniMed Paradigm infusion pump or syringe. It is inserted into the subcutaneous tissue of a patient and the Simplicity YP connector is attached to the medication reservoir. The device consists of four main parts: (1) an infusion catheter made from PTFE, (2) an infusion hub that provides the patient the capability of disconnecting tube from the infusion catheter, (3) a connecting tube and (4) a Simplicity YP connector consisting of a needle hub and reusable pump adapter and reservoir connector. The Simplicity QD Easy P Infusion Set is an infusion administration set, connecting to the Paradigm reservoir by means of a Simplicity YP connector consisting of a needle hub and reusable pump adapter and reservoir connector and subcutaneously in the patient through an indwelling catheter made of Polytetrafluorthylene (PTFE). The Sterling Medivations Simplicity QD Easy P Infusion Set may be used with any paradigm infusion device that delivers continuous or intermittent flow. The connecting tubing is made from a polyethylene tube. The 25 gauge-indwelling catheter is introduced into the subcutaneous tissue by a removable 27-gauge insertion needle formed from a lumen made of AISI 304 stainless steel. The insertion needle is removed and a connector needle is attached to the indwelling catheter. This connector needle mates with the indwelling catheter forming a seal that permits the infusion of medication without leakage. The connector needle is made from AISI 304 stainless steel and it is connected to the connecting tubing with a connector housing. The connector tubing proximal end is attached to a Simplicity YP connector consisting of a needle hub and reusable pump adapter and reservoir connector for connection to a MiniMed Paradigm pump and reservoir. The connecting tube is solvent bonded to the connector housing and to the needle hub connector.

The intended use of the Simplicity Simplex P Infusion Set is to provide a means for infusion and/or injection of fluids into the body the surface of the skin when attached to a MiniMed Paradigm pump or syringe.

Sterling Medivations Inc.'s ("SMI") Simplicity™ Simplex P Infusion Set is designed to provide a nicans to infuse or inject medication subcutaneously when attached to the MiniMed Paradigni infusion pump or syringe. The Simplicity Simplex P Infusion Set is designed for use by people with diabetes to provide a means to infuse or inject medication subcutaneously when attached to the MiniMcd Paradigm influsion purpor syringe. It is inserted into the subcutaneous tissue of a patient and the Simplicity YP concector is stached to the medication reservoir. This is substantially equivalent to the predicate device and it has the same intendcd use. The device cousists of four main parts: (1) an infusion catheter made from PTFE, (2) an infusion lub that provides the patient the capability of disconnecting the comnecting tube from the infusion catheren (3) a connecting tube and (4) a Simplicity YP connector consisting of a needle hub and reused causes. (1) a and reservoir connector. The Simplicity Simplex P Infusion Set is an infusion administration set, connecting to the Paradig m reservoir by means of a Simplicity YP connector consisting of a needle but and reuseble purpose and rescrvoir connector and subcutancously in the patient through an indwelling catheter made of Polytetrafluorthylene (PTFE). The Stcrling Medivations Simplicity Simplex P Infusion Set may je used with any paradigm infusion device that delivers continuous or internattent flow. The connecting tubing is made from a polyethylene tube. The 25 gauge-indwelling catheter is introduced into the subcutancous tissue by a removable 27-gauge insertion necdle formed from a lumen made of AISI 304 stainless stecl. The insertion needle is removed and a connector needle is attached to the indwelling catheter. This connector ne-dle mates with the indwelling catheter forming a seal that permits the infusion of medication without leakage. The connector needle is made from AISI 304 stainless stcel and it is connected to the connecting tubing with a connector housing. The connector tubing proximal end is attached to a Simplicity YP connector consisting of a needle bub and reusable pump adapter and reservoir connection to a MiniMed Paradign pump and reservoir. The connecting tube is solvent bonded to the connector housing and to the aecdle hub

The intended use of the Simplicity Easy Access II Infusion Set is to provide a means & for infusion and/or injection of fluids into the body below the surface of the skin when attached to an external pump or syringe.

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The intended use of the Simplicity Easy Soft Infusion Set is to provide a means to for infusion and/or injection of fluids into the body below the surface of the skin when attached to an external pump or syringe.

Sterling Medivations Inc.'s ("SMI") Simplicity Easy Soft Infusion designed for infusion and/or injection of fluids into the body below the surface of the skin when attached to a external pump or syringe. The device consists of four main parts: (1) infusion catheters are made from Polytetrafluoroethylene (PTFE), (2) an infusion hub that provides the patient the capability of disconnecting tube from the infusion catheter, (3) a connecting tube and threaded reservoir connector and (4) an insertion needle ring. The Simplicity Easy Soft Infusion Set is an infusion administration set, connecting to a medicine reservoir or syringe that is placed in an external infusion device and inserted below the surface of the skin of a patient. The SMI Simplicity Easy Soft Infusion Set may be used with any infusion device that delivers continuous or intermittent flow. The administration set attaches to the reservoir/svringe by means of a threaded luer connector, and under the surface of the skin in the patient through an indwelling cannula formed from PTFE. The connecting tubing is made from a polyethylene tube. The PTFE indwelling cannula are insertion needles formed from AISI 304 stainless steel are introduced below the surface of the skin. The insertion needle is removed and the connector needle is attached to the hub fixed to the indwelling catheter. This seal on the connector needle mates with the indwelling catheter hub that forms a seal that permits the infusion of medication without leakage. The connector needle is made from AISI 304 stainless steel and it is connecting tubing. The connector tubing proximal end is attached to a threaded luer connector for attachment to the medicine reservoir.

The intended use is to provide a means to infuse or inject insulin subcutaneously when used with any infusion device that delivers continuous or intermittent flow.

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The intended use of the Simplicity Simplex Soft Infusion Set is to provide a means for infusion and/or injection of fluids into the body below the surface of the skin when attached to an external pump or syringe.

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The intended use of the Simplicity StarPlus Soft Infusion Set is to provide a means for infusion and/or injection of fluids into the body below the surface of the skin when attached to an external pump or syringe.

Sterling Medivations, Inc.'s ("SMI") Simplicity ™ StarPlus Soft Infusion Set is designed for use by people with diabetes to infuse insulin subcutaneously from a pump or syringe. The device consists of four main parts: (1) an infusion catheter made from polytetrafluorthylene (PTFE), (2) an infission hub that provides the patient the capability of disconnecting tube from the infusion catheter, (3) a comecting tube and (4) a female Luer connector. The Simplicity StarPlus Soft Infusion Set is an infusion administration set, connecting to a pump or syringe and inserted in the subcutaneous tissue of a patient. The Sterling Medivations Simplicity StarPlus Soft Infusion Set may be used with any infusion device that delivers continuous or intermittent flow. The administration set attaches to the pump or syringe by means of a female Luer connector, and subcutaneously in the patient through an indwelling catheter made of polytetrafluorthylene (PTFE). The connecting tubing is made from a polyethylene tube. The 25 gauge-indwelling PTFE catheter is introduced into the subcutaneous tissue using an insertion needle. The insertion needle is removed and a connector housing is attached to the indwelling catheter. This connector needle part of the connector hub pierces a septum formits the infusion of medication without leakage. The connector needle is connected to the connector housing. The connector housing. The connector tubing proximal end is attached to a female Luer connector for attachment to the medicine reservoir. The connecting tube is solvent bonded to the connector housing and to the Luer connector. The quick disconnect allows the patient to temporally disconnect the pump reservoir from the indwelling catheter to better facilitate bathing and reservoir changes.

The intended use of the Simplicity Easy Access Infusion Set is to provide a means for infusion and/or injection of fluids into the body below the surface of the skin when attached to an external pump or syringe.

Sterling Medivations Inc.'s ("SMI") Simplicity Easy Access Infusion Set is designed for infusion and/or injection of fluids into the body below the surface of the skin when attached to an external pump or syringe. The device consists of four main parts: (1) infusion catheters made from AISI 304 stainless steel, (2) an infusion hub that provides the patient the capability of disconnecting the connecting tube from the infusion catheter, (3) a connecting tube and (4) a threaded reservoir connector. The Simplicity Easy Access Infusion Set is an infusion administration set, connecting to a medicine reservoir or syringe that is placed in an external infusion device and inserted below the surface of the skin of a patient. The SMI Simplicity Easy Access Infusion Set may be used with any infusion device that delivers continuous or intermittent flow. The administration set attaches to the reservoir/syringe by means of a threaded luer connector, and under the surface of the skin in the patient through an indwelling needles formed from AISI 304 stainless steel. The connecting tubing is made from a polyethylene tube. The indwelling needles formed from AISI 304 stainless steel are introduced below the surface of the skin. The connector needle is attached to the indwelling catheter. This seal on the connector needle mates with the indwelling catheter hub that forms a seal that permits the infusion of medication without leakage. The with and me work is made from AISI 304 stainless steel and it is connecting tubing. The connecting tubing. The connector tubing proximal end is attached to a threaded luer connector for attachment to the medicine reservoir.