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    K Number
    K201634
    Device Name
    RG 3ml Medication Cartridge
    Manufacturer
    Chengdu Shifeng Medical Technology Co., Ltd.
    Date Cleared
    2021-03-26

    (283 days)

    Product Code
    MRZ
    Regulation Number
    880.5725
    Why did this record match?
    Applicant Name (Manufacturer) :

    Chengdu Shifeng Medical Technology Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The RG 3ml Medication Cartridge is designed for use in hospitals and outpatient care environments with the CADD-MS®3 Ambulatory Infusion Pump for subcutaneous infusion of medication in adults.
    Device Description
    The RG 3ml Medication Cartridge is a sterile, single-use, non-pyrogenic, 3.0 ml piston syringe intended for use with the Smiths Medical MD, Inc. CADD-MS®3 Ambulatory Infusion Pump. The CADD-MS®3 Ambulatory Infusion Pump requires use of a 3 ml medication cartridge and an infusion set. The RG 3ml Medication Cartridge consists of a hollow barrel, movable plunger with O-rings for sealing and a male Luer lock fitting at the distal end. The male Luer lock fitting of the cartridge is connected to the female Luer fitting of an infusion set. The reservoir is placed in the CADD-MS®3 Ambulatory Infusion Pump to achieve its intended use. The RG 3ml Medication Cartridge is available with a 0.7mm (22G) x 12.5mm (1/2in.) needle and cap. The needle is attached to the end of the RG 3ml Medication Cartridge and operates as a syringe to withdraw medication from a vial. After the medication is filled in the RG 3ml Medication Cartridge, the plunger stopper is removed to allow the RG 3ml Medication Cartridge to fit inside the Smiths CADD-MS®3 Infusion Pump. A cartridge cap from the Smiths CADD-MS®3 Infusion Pump secures the RG 3ml Medication Cartridge into place. An infusion set is then attached to the luer lock fitting of the RG 3ml Medication Cartridge.
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