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510(k) Data Aggregation

    K Number
    K230718
    Device Name
    UTC 3mL Medication Cartridge
    Manufacturer
    Gilero, LLC
    Date Cleared
    2023-06-15

    (92 days)

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

    Gilero, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The UTC 3 ml Medication Cartridge is intended for use in hospital and outpatient care environments with the CADD-MS® 3 Ambulatory Infusion Pump for subcutaneous infusion of medication in adults.
    Device Description
    The UTC 3 mL Cartridge (UTC Cartridge) is a is a sterile, single-use cartridge intended for use with the Smiths Medical MD, Inc. CADD-MS®3 Ambulatory Infusion Pump. The UTC Cartridge is for use in hospitals and outpatient care environments. The UTC 3 mL Medication Cartridge consists of 3 primary components: a 3mL cartridge that looks like a small syringe, 22G x 0.5 in. needle, and protective cap. The distal end of the device has a male luer lock used to attach the needle and withdraw medication from a vial. Once filled, the plunger is removed, needle is discarded, and protective cap is place on the luer until the cartridge is inserted into the CADD-MS 3 Infusion Pump and secured into place with the infusion pump's lid. The protective cap can then be discarded and the male luer can then be attached to the female luer of an infusion set.
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    K Number
    K201936
    Device Name
    SmartSite Bag 500mL, SmartSite Bag 250 mL, SmartSite Bag 100 mL
    Manufacturer
    Gilero, LLC
    Date Cleared
    2021-05-06

    (297 days)

    Product Code
    KPE
    Regulation Number
    880.5025
    Why did this record match?
    Applicant Name (Manufacturer) :

    Gilero, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SmartSite™ Bag is an empty container used for administration of intravenous solutions to the patient using an intravascular administration set. Medication transfer in and out of the container is done using aseptic technique.
    Device Description
    The SmartSite™ Bag is a single-use, empty IV container, which will be available in 100mL, 250mL, and 500mL product sizes. The SmartSite™ Bag is labeled as sterile fluid path, and contains both an add port and a spike port. The add port facilitates aseptic transfer of medication(s) into or out of the bag. The spike port contains a twist-off protective seal. Either the add port or the spike port can be connected to an intravenous (IV) administration set for medication delivery to the patient. The add port may be repeatedly accessed in accordance with the Directions for Use (DFU). The SmartSite™ Bag may be used for up to 24 hours after the initial access of the add port, consistent with prescribing information for the medications used.
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