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510(k) Data Aggregation

    K Number
    K003827
    Device Name
    PUNCTUR-GUARD WINGED SET FOR BLOOD COLLECTION
    Manufacturer
    BIO-PLEXUS, INC.
    Date Cleared
    2001-01-08

    (28 days)

    Product Code
    FMI
    Regulation Number
    880.5570
    Why did this record match?
    Applicant Name (Manufacturer) :

    BIO-PLEXUS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K992091
    Device Name
    PUNCTUR-GUARD REVOLUTION HOLDER, MODEL 4750
    Manufacturer
    BIO-PLEXUS, INC.
    Date Cleared
    1999-09-09

    (80 days)

    Product Code
    FMI
    Regulation Number
    880.5570
    Why did this record match?
    Applicant Name (Manufacturer) :

    BIO-PLEXUS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The REVOLUTION Holder is used in blood drawing procedures. It is used with PUNCTUR-GUARD® Blood Collection Needles only, and is compatible with standard blood sample tubes as well as pediatric inserts. The REVOLUTION Holder should be used by health care workers experienced in phlebotomy. At the end of a blood draw, the holder dial is rotated clockwise 90°. This rotation activates the safety mechanism of the PUNCTUR-GUARD® needle, which reduces the probability of an accidental needle stick. The needle can be eliminated quickly by a push on the release button. The holder is re-usable for up to 100 draws, including 20 cleanings.
    Device Description
    The REVOLUTION Holder is designed to hold PUNCTUR-GUARD® Blood Collection Needles during blood drawing procedures, and to allow blunting of PUNCTUR-GUARD® needles prior to removal from the patient. Blunting reduces the probability of accidental needle sticks which are a major risk for infection with HIV or hepatitis. Blunting is performed by turning the dial at the holder's end. The REVOLUTION Holder is non-sterile and can be used for up to 100 blood draws, including 20 cleanings. Contaminated needles can be released quickly in a one-handed operation by a manual push on the release button.
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    K Number
    K963748
    Device Name
    BIO-PLEXUS DROP-IT NEEDLE HOLDER
    Manufacturer
    BIO-PLEXUS, INC.
    Date Cleared
    1997-06-06

    (262 days)

    Product Code
    FMI, DAT, REA
    Regulation Number
    880.5570
    Why did this record match?
    Applicant Name (Manufacturer) :

    BIO-PLEXUS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Bio-Plexus DROP-IT® Needle Holder is a venipuncture needle holder which is recommended for use with standard blood collection needles including the PUNCTUR-GUARD® Blood Collection Needle as well as PUNCTUR-GUARD® Winged Sets for Blood Collection. It also mates with the Bio-Plexus Needle Disposal Container for easy needle disposal. This is a non-sterile reusable device recommended for a maximum of 100 uses.
    Device Description
    The Bio-Plexus DROP-IT® Needle Holder is a venipuncture needle holder comprised of an assembly of 5 plastic injection molded parts. The device rigidly holds a blood collection needle during the venipuncture procedure and also allows the needle to be released by use of a pushbutton rather than by unwinding. This device is for use with standard blood collection needles including Punctur-Guard® blood collection needles and winged sets. Standard blood collection needles include the Becton Dickinson Vacutainer® Needle, the Sherwood Monoject® Needle and the Terumo Venoject® Needle. The DROP-IT® Needle Holder performs the same functions as other legally marketed needle holders, for example, the Vacutainer® Brand Needle Holder #4893 and the Sage Products AutoDrop® Needle Holder #1510.
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    K Number
    K960933
    Device Name
    BIO-PLEXUS NEEDLE DISPOSAL CONTAINER
    Manufacturer
    BIO-PLEXUS, INC.
    Date Cleared
    1996-08-28

    (174 days)

    Product Code
    FMI, REA
    Regulation Number
    880.5570
    Why did this record match?
    Applicant Name (Manufacturer) :

    BIO-PLEXUS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Not Found
    Device Description
    The BIO-PLEXUS™ Needle Disposal Container is a single use, one quart, puncture resistant container comprised of a bucket like base and an affixed cover. The bucket and the cover are plastic injection molded from polypropelene. The cover has three openings and two hinged lids.
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    K Number
    K961251
    Device Name
    PUNCTUR-GUARD WINGED SET
    Manufacturer
    BIO-PLEXUS, INC.
    Date Cleared
    1996-06-27

    (87 days)

    Product Code
    FMI, REA
    Regulation Number
    880.5570
    Why did this record match?
    Applicant Name (Manufacturer) :

    BIO-PLEXUS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    provides sterile vascular access for the collection of blood utilizing a vacuum tube system or syringe. allows vascular access with a low entry angle and firm needle tip control. permits collection of blood via a flexible tubing, effectively dissociating the puncture site from the proximal end of the device.
    Device Description
    The PUNCTUR-GUARD® Winged Set is comprised of a sharp, lubricated stainless steel front needle which is attached to a flexible winged body. A blunt inner cannula is contained inside the front needle and provides the fluid path. A third wing is provided to actuate the blunting cannula forward of the needle point. The third wing is connected to flexible tubing at the end of which is a female luer connector. The device will be available in two configurations, with a male luer cap covering the female luer connector or with a Multi-Sample Lure Adapter (MSLA) attached to the female luer connector. The MSLA is comprised of a valved needle, hub with female luer connector and threaded section for the attachment of a holder. BIO-PLEXUS manufactures a one piece Needle Holder.
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