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These infusion sets are indicated for the subcutaneous infusion of medication from an external Infusion Pump.

The asante comfort™ Subcutaneous Infusion Sets for use with the Asante Pearl™ pump and the currently marketed Comfort™ Subcutaneous Infusion Sets are both sterile, non-pyrogenic, single use subcutaneous infusion sets. For the connection to the infusion set, the current Comfort™ sets have a standard female luer connector compatible with many commercially available infusion devices while the new asante comfort™ sets have the unique connector/adapter only compatible with the Asante Insulin Infusion Pump cleared as part of the Asante Pearl™ Diabetes Management System 510(k), file number K100567. This connector/adapter is provided to Unomedical as a finished, tested component by Asante Solutions, the manufacturer of the Asante Pump, and is bonded,us ing the same adhesive, to the pump end of a standard Comfort™ infusion set in lieu of the female luer by Unomedical. The remainder of the set, including all fluid contact materials, sterile packaging, and the manufacturing and sterilization process are unchanged. The method of use of the devices is the same as for the unmodified devices including attaching the connector end of the set to the pump per the pump manufacturers' instructions and the use of the pump with the Comfort™ Subcutaneous Infusion Sets were included as part of the Asante 510(k) file. The asante conset™ Subcutaneous Infusion Sets for use with the Asante Pearl™ pump and the current Inset™ Subcutaneous infusion Sets are both sterile, nonpyrogenic, single use subcutaneous infusion sets with an integrated springpowered catheter insertion device. For the connection to the infusion set, the current Inset™ infusion sets have a standard luer connector compatible with commercially available infusion devices while the new Asante Conset™ sets have a unique connector/adapter compatible with the Asante Pearl™ Infusion Pump cleared as part of the Asante Pearl™ Diabetes Management System 510(k), file number K100567. This part is provided to Unomedical as a finished, tested component by Asante Solutions, the manufacturer of the Asante Pump, and is bonded, using the same adhesive, to the pump end of a standard Inset™ infusion set in lieu of the female luer by Unomedical. The remainder of the set, including all fluid contact materials, sterile packaging, and the manufacturing and sterilization process are unchanged. The method of use of the devices is the same as for the unmodified devices including attaching the connector end of the set to the pump per the pump manufacturers' instructions and the use of the pump with the Inset™ Subcutaneous Infusion Sets were included as part of the Asante 510(k) file.