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    K Number
    K971313
    Device Name
    NMC HEMODIALYSIS ARTERIAL BLOOD TUBING SET
    Manufacturer
    NATIONAL MEDICAL CARE, INC.
    Date Cleared
    1997-10-27

    (201 days)

    Product Code
    FJK
    Regulation Number
    876.5820
    Why did this record match?
    Applicant Name (Manufacturer) :

    NATIONAL MEDICAL CARE, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Hemodialysis Arterial Blood Tubing Set is intended for use as the extra corporeal blood circuit during hemodialysis. It is intended for single use only. The Hemodialysis Arterial Blood Tubing Set is indicated for use with conventional and high flux negative pressure hemodialyzer equipment.
    Device Description
    The proposed hemodialysis arterial blood tubing sets raise no new issues of safety or efficacy. Sterilization method and packaging are essentially the same. The arterial bloodlines are substantially equivalent to legally marketed bloodlines. These bloodlines have been functionally tested and data provided. The blood contact materials of the arterial bloodlines have been tested for biocompatibility and data provided. The integrity of the bonded connections of the bloodlines have been tested and data provided.
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    K Number
    K971687
    Device Name
    HEMODIALYSIS VENOUS BLOOD TUBING SET OR SIMILAR TRADE NAME
    Manufacturer
    NATIONAL MEDICAL CARE, INC.
    Date Cleared
    1997-07-29

    (88 days)

    Product Code
    FJK
    Regulation Number
    876.5820
    Why did this record match?
    Applicant Name (Manufacturer) :

    NATIONAL MEDICAL CARE, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Hemodialysis Venous Blood Tubing Set is intended for use as the extracorporeal blood circuit during hemodialysis. It is intended for single use only. The Hemodialysis Venous Blood Tubing Set is indicated for use with conventional and high flux negative pressure hemodialyzer equipment.
    Device Description
    The proposed hemodialysis venous blood tubing sets raise no new issues of safety or effectiveness. No new claims or indications are made. The venous bloodlines are substantially equivalent to legally marketed bloodlines. These bloodlines have been functionally tested and data provided. The blood contact materials of the venous bloodlines have been tested for biocompatibility and data provided. The integrity of the bonded connections of the bloodlines have been tested and data provided. Sterilization method and packaging are the same as the predicate devices.
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