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Unomedical Monica Infusion Sets are indicated for the subcutaneous infusion of medication from an external pump.

The Unomedical Monica Set is an infusion administration set, connecting to a reservoir/infusion pump and inserted in the subcutaneous tissue of a user. The administration set attaches to the reservoir by means of a "tubing connector", and subcutaneously in to the user through an indwelling catheter made of polytetrafluoroethylene (PTFE). The tubing is made of two layers: the inner layer is polyethylene; the outer is polyurethane. The indwelling catheter is introduced into the subcutaneous tissue by a removable 27 gauge introducer needle (cannula) made of AISI 304 stainless steel.

This document is a 510(k) summary for the Unomedical Monica Infusion Set, which is a submission to the FDA. It does not contain information about acceptance criteria or a study demonstrating the device meets such criteria. Instead, it details the device description, its intended use, and compares it to predicate devices to establish substantial equivalence for regulatory approval.

Therefore, I cannot provide the requested information based on the provided text. The submission focuses on regulatory approval based on equivalence to existing devices, not on performance against specific acceptance criteria for a new study.

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