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510(k) Data Aggregation

    K Number
    K162110
    Device Name
    CORGRIP NG/NI Tube Retention System
    Manufacturer
    CORPAK MedSystems, Inc. a Division of Haylard Health
    Date Cleared
    2016-09-15

    (48 days)

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

    CORPAK MedSystems, Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The CORGRIP Nasogastric/Nasointestinal (NGNI) Tube Retention System is indicated for use with enteral feeding tubes of 8 FR and greater and NG decompression, suction and drainage tubes up to 18 FR to prevent inadvertent removal or displacement of the tubes for adult patients.
    Device Description
    The CORGRIP NG/NI Tube Retention System is an accessary to prevent unwanted displacement or removal of nasogastric/nasojejunal tubes for adult patients by retaining the tube to the patient's nasal septum. The device consists of three main components: insertion (delivery) catheter, retrieval catheter, and tube clamp. The catheters are placed in either nare of the patient and the clinician maneuvers the catheters to connect the magnets at the back of the patient's nasal septum. Both catheters have a flexible tip to aid in magnet connection. Once connection is made the magnet on the insertion catheter is pulled through the nare by the retrieval catheter. Both catheters are then removed from each nare until the ends of the umbilical tape are exiting either nare. The umbilical tape is then secured to the feeding tube with the provided clamp. The proposed device adds the option of a 14, 16 and 18 Fr clamp.
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    K Number
    K142012
    Device Name
    FARRELL VALVE SYSTEM WITH EQUILIBRIUM TECHNOLOGY AND ENFIT ENTERAL CONNECTORS
    Manufacturer
    CORPAK MEDSYSTEMS
    Date Cleared
    2014-11-20

    (119 days)

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

    CORPAK MEDSYSTEMS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The FARRELL® Valve System with EQUILIBRIUM TECHNOLOGY™ and ENFit™ Enteral Connectors is a closed reservoir system intended to allow the evacuation of excess gas (gastric distention/bloating) and drainage/collection of enteral feeding formula and gastrointestinal tract contents from patients utilizing an enteral device. The FARRELL® Valve System with EQUILIBRIUM TECHNOLOGY™ and ENFit™ Enteral Connectors is for use with neonates, pediatric, and adult patients.
    Device Description
    Not Found
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    K Number
    K133599
    Device Name
    CORGRIP
    Manufacturer
    CORPAK MEDSYSTEMS
    Date Cleared
    2014-03-26

    (121 days)

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

    CORPAK MEDSYSTEMS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The CORGRIP Nasogastric/Nasointestinal (NG/NI) Tube Retention System is indicated for use with CORPAK MedSystems enteral feeding tubes of 8 Fr and greater to prevent inadvertent removal or displacement of the tubes for adult patients.
    Device Description
    Not Found
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    K Number
    K131532
    Device Name
    ELECTROMAGNETIC TRANSMITTING STYLET
    Manufacturer
    CORPAK MEDSYSTEMS
    Date Cleared
    2013-08-12

    (76 days)

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

    CORPAK MEDSYSTEMS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Electromagnetic Transmitting Stylet has been specifically designed for use with the CORTRAK 2 Enteral Access System (EAS), and is intended to aid in the confirmation of NG decompression tubes.
    Device Description
    Electromagnetic Transmitting Stylet
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    K Number
    K113351
    Device Name
    CORTRAK ENTERAL ACCESS DEVICE
    Manufacturer
    CORPAK MEDSYSTEMS
    Date Cleared
    2012-01-10

    (57 days)

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

    CORPAK MEDSYSTEMS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The CORTRAK 2 System is an electrical device designed to aid qualified operators in the placement of the CORPAK MedSystems feeding tubes of 8 FR or greater into the stomach or small bowel of patients requiring enteral feeding. CORTRAK 2 can be used to confirm placement of feeding tubes prior to commencing the delivery of enteral nutrition.
    Device Description
    The CORTRAK 2 System is an electrical device.
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    K Number
    K100365
    Device Name
    FARRELL VALVE WITH CORFLO ANTI-IV CONNECTORS MODEL 20-4300AIV
    Manufacturer
    CORPAK MEDSYSTEMS
    Date Cleared
    2010-05-20

    (97 days)

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

    CORPAK MEDSYSTEMS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Farrell Valve is a reservoir system intended to allow the evacuation of excess gas(gastric distention/bloating) and enteral feeding formula from the stomach of patients receiving enteral formula via feeding tubes and sets. Farrell Valve with CORFLO ANTI IV Connectors is for use with pediatric patients.
    Device Description
    Not Found
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    K Number
    K091637
    Device Name
    CORTRAK ENTERAL ACCESS DEVICE, MODEL 20-0900
    Manufacturer
    CORPAK MEDSYSTEMS
    Date Cleared
    2009-09-29

    (117 days)

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

    CORPAK MEDSYSTEMS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K083776
    Device Name
    CORFLO ANTI IV ENTERAL FEEDING SET, MODEL: 20-1030AIV-LB-S
    Manufacturer
    CORPAK MEDSYSTEMS
    Date Cleared
    2009-03-05

    (76 days)

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

    CORPAK MEDSYSTEMS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The CORFLO Anti-IV Enteral Feeding Extension Set is intended to be used to deliver enteral formula from the nutritional source to any enteral feeding device accepting standard enteral step connectors. The CORFLO Anti-IV Enteral Feeding Extension Set is for pediatric and neonatal use only.
    Device Description
    CORFLO Anti-I.V. Enteral Feeding Extension Set Model# 20-1030AIV-LB-S
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    K Number
    K083791
    Device Name
    CORFLO ANTI IV ENTERAL FEEDING SET, MODEL: 20-1060AIV-S
    Manufacturer
    CORPAK MEDSYSTEMS
    Date Cleared
    2009-03-04

    (75 days)

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

    CORPAK MEDSYSTEMS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The CORFLO Anti-I.V. Enteral Feeding Extension Set is intended to be used to deliver enteral formula from the nutritional source to any enteral feeding device acccepting a standard enteral step connector. The CORFLO Anti-IV Enteral Feeding Extension Set is for pediatric and neonatal use only.
    Device Description
    Not Found
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    K Number
    K083786
    Device Name
    CORFLO ANTI-IV ENTERAL FEEDING EXTENSION SET, MODELS 20-1006AIV-LB AND 20-1030AIV-LB
    Manufacturer
    CORPAK MEDSYSTEMS
    Date Cleared
    2009-02-20

    (63 days)

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

    CORPAK MEDSYSTEMS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The CORFLO Anti-IV Enteral Feeding Extension Set is intended to be used to deliver enteral formula from the nutritional source to the Anti IV Enteral feeding tube. The CORFLO Anti-IV Enteral Feeding Extension Set is for pediatric and neonatal use only.
    Device Description
    Not Found
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