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510(k) Data Aggregation

    K Number
    K072518
    Device Name
    CRS FIBRIN ANALYSIS CATHETER TESTING SYSTEM (FACTS)
    Date Cleared
    2007-12-20

    (104 days)

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

    CRS MEDICAL DIAGNOSTICS INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The CRS Fibrin Analysis Catheter Testing System (FACTS) is intended to collect and remove obstructing material from the internal lumen surface of an indwelling central venous catheter to restore or improve catheter flow rate, and to provide a biofilm or fibrin sample which is suitable for microbiological analysis.
    Device Description
    The CRS Fibrin Analysis Catheter Testing System (FACTS) is an accessory to peripherally inserted central catheters (PICC). Each single use FACTS kit contains complete instructions for use, 2 pr nitrile powder free gloves (med), 2 each ear loop procedure face masks, 3 each alcohol swabs, 1 each BD Lure-Loc Access Device, 2 each vacutainer tube, 1 each test brush in sheath, 1 each over wrap drape, 1 each measure tape, 1 each clamp and 1 cach specimen transport bag. The testing brush consists of nylon bristles wound onto a flexible stainless steel wire. The testing brush is enclosed within a polysheath that is heat sealed at the distal end and again at the brush handle and is attached by color coded rings. The different rings indicate the diameter of the testing brush bristles.
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    K Number
    K050889
    Device Name
    FIBRIN ANALYSIS SYSTEM ENDOLUMINAL BRUSH
    Date Cleared
    2005-08-26

    (142 days)

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

    CRS MEDICAL DIAGNOSTICS INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The CRS Endoluminal Brush is intended to collect a biofilm or fibrin sample, which is suitable for microbiological analysis, from the inner lumen surface of an in-dwelling central venous catheter
    Device Description
    The CRS Endoluminal Brush product line is an accessory to central venous catheters. Each single use Endoluminal Brush kit contains 2 pairs of latex free gloves, 1- 70% isopropyl alcohol cleaning agent, 1 fibrin brush in transport bag, 1- 10 cc syringe, 2 patient labels, 1 medical drape, 1 over wrap, and Instructions for Use. The brush consists of nylon bristles wound into a flexible stainless steel wire, which is further wound into a tubular, metal, rigid handle. The Brush is enclosed within a no ratiner would at the distal end and is attached to a standard luer lock at its proximal end. The luer lock fitting complies with catheter manufacturers' requirement that only luer-lock connections be used with catheters. The various CRS Endoluminal Brush products defined by the product codes differ mainly in the length of the flexible wire and the diameter of the Brush bristles.
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