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510(k) Data Aggregation

    K Number
    K070048
    Device Name
    GUARDIAN CATHETER-INFANT URINARY COLLECTION KIT
    Manufacturer
    MARIAN MEDICAL, INC.
    Date Cleared
    2007-03-15

    (71 days)

    Product Code
    FCM
    Regulation Number
    876.5130
    Why did this record match?
    Applicant Name (Manufacturer) :

    MARIAN MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The GuardianCatheter-Infant Urinary Collection Kit is for urinary drainage and collection for use in the neonatal/pediatric patient population.
    Device Description
    Not Found
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    K Number
    K063795
    Device Name
    GUARDIANCATHETER-URINARY DRAINAGE CATHETER
    Manufacturer
    MARIAN MEDICAL, INC.
    Date Cleared
    2007-03-05

    (73 days)

    Product Code
    GBM
    Regulation Number
    876.5130
    Why did this record match?
    Applicant Name (Manufacturer) :

    MARIAN MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The GuardianCatheter-Infant Urinary Drainage Catheter is a single lumen silicone urinary catheter intended to drain urine in the neonatal patient population. This catheter is NOT a Foley (balloon) type catheter.
    Device Description
    The GuardianCatheter-Infant Urinary Drainage Catheter is a single lumen silicone urinary catheter.
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    K Number
    K050542
    Device Name
    MARIAN INFANT FEEDING TUBE (GUARDIANPICC PERCUTANEOUS CENTRAL VENOUS CATHETER
    Manufacturer
    MARIAN MEDICAL, INC.
    Date Cleared
    2005-07-26

    (146 days)

    Product Code
    LJS
    Regulation Number
    880.5970
    Why did this record match?
    Applicant Name (Manufacturer) :

    MARIAN MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The GuardianPICC™ is a sterile, disposable, single lumen catheter intended for I.V. administration. The catheter may be used for delivery of TPN nutritional solutions, antibiotics, pain medications, chemotherapy and hurritional concernis inserted peripherally and provides a mechanism for the administration of IV medications to the large central veins of the body.
    Device Description
    The GuardianPICC™ is a sterile, disposable, single lumen catheter intended for I.V. administration.
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    K Number
    K042112
    Device Name
    INFANT FEEDING TUBE
    Manufacturer
    MARIAN MEDICAL, INC.
    Date Cleared
    2005-01-28

    (176 days)

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

    MARIAN MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The GuardingCatheter - Infant Feeding Tube is a sterile, disposable silicone catheter intended to deliver nutritional media. The catheter is inserted into the stomach or intestine-small bowel through the nares or mouth for delivery of liquid nutritional diets to patients with a functional GI tract.
    Device Description
    The GuardingCatheter - Infant Feeding Tube is a sterile, disposable silicone catheter intended to deliver nutritional media.
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