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    K Number
    K190310
    Device Name
    U Deliver Bolink ENFit Enteral Feeding Sets
    Manufacturer
    U Deliver Medical, LLC
    Date Cleared
    2019-05-31

    (108 days)

    Product Code
    PIF
    Regulation Number
    876.5980
    Why did this record match?
    Applicant Name (Manufacturer) :

    U Deliver Medical, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The U Deliver Bolink ENFit Enteral Feeding Sets are intended for over-the-counter use to deliver liquid nutritional formulas or water to a patient's enteral access device (feeding tube).
    Device Description
    The U Deliver Bolink ENFit Enteral Feeding Sets consist of two configurations: - U Deliver Bolink Small Cap Gravity Feeding Set with Cross Spike and ENFit Connector (ref. BK-2085) . - U Deliver Bolink Large Cap Gravity Feeding Set with ENFit Connector (ref: BK-2405) The U Deliver Bolink Small Cap Gravity Feeding Set with Cross Spike and ENFit Connector uses the free flow of gravity to dispense enteral feeding solutions from a distal reservoir (not supplied) which connects via a safety screw connection meeting the requirements of clauses 4 "General requirement" and 5 "Dimensional requirements for enteral feed reservoir connectors" of ISO18250-3, "Connectors for reservoir delivery systems for healthcare applications - Part 3: Enteral applications', to a PVC tube with external clamp, to a distal ENFit connector, meeting the requirements of ISO 80369-3, 'Small-bore connectors for liquids and gases in healthcare applications - Part 3: Connectors for enteral applications'. The U Deliver Bolink Large Cap Gravity Feeding Set with ENFit Connector uses the free flow of gravity to dispense enteral feeding solutions from a distal reservoir (not supplied) which connects via a screw cap with a 40 mm thread, to a PVC tube with external clamp, to a distal ENFit connector, meeting the requirements of ISO 80369-3 Both sets are constructed from medical grade, biocompatible materials, and are supplied non-sterile for single patient use only.
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    K Number
    K170555
    Device Name
    U Deliver Bolink ENFit Enteral Feeding Sets
    Manufacturer
    U Deliver Medical, LLC
    Date Cleared
    2017-08-17

    (174 days)

    Product Code
    PIF
    Regulation Number
    876.5980
    Why did this record match?
    Applicant Name (Manufacturer) :

    U Deliver Medical, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The U Deliver Bolink ENFit Enteral Feeding Sets are intended to deliver liquid nutritional formulas or water to a patient's enteral access device (feeding tube).
    Device Description
    The U Deliver Bolink ENFit Enteral Feeding Sets consist of two configurations: - U Deliver Bolink Small Cap Gravity Feeding Set with Cross Spike and ENFit Connector (ref. . BK-1085) - U Deliver Bolink Large Cap Gravity Feeding Set with ENFit Connector (ref: BK-1405) . The U Deliver Bolink Small Cap Gravity Feeding Set with Cross Spike and ENFit Connector uses the free flow of gravity to dispense enteral feeding solutions from a distal reservoir (not supplied) which connects via a safety screw connection meeting the requirements of clauses 4 "General requirement" and 5 "Dimensional requirements for enteral feed reservoir connectors" of ISO/DIS 18250-3. 'Connectors for reservoir delivery systems for healthcare applications - Part 3: Enteral applications', to a PVC tube with external clamp, to a distal ENFit connector, meeting the requirements of ISO 80369-3, 'Small-bore connectors for liquids and gases in healthcare applications - Part 3: Connectors for enteral applications'. The U Deliver Bolink Large Cap Gravity Feeding Set with ENFit Connector uses the free flow of gravity to dispense enteral feeding solutions from a distal reservoir (not supplied) which connects via a screw cap with a 40 mm thread, to a PVC tube with external clamp, to a distal ENFit connector, meeting the requirements of ISO 80369-3 Both sets are constructed from medical grade, biocompatible materials, and are supplied non-sterile for single patient use only.
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