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510(k) Data Aggregation

    K Number
    K020921
    Device Name
    NO-POKES NEEDLE SAFETY DEVICE
    Manufacturer
    BEMIS MFG. CO.
    Date Cleared
    2002-07-11

    (112 days)

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

    BEMIS MFG. CO.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    NO-POKES™ is a disposable needle recapping aid that helps prevent recapping injury by providing repository for the needle cap (other than the user's hand) in which to place the cap while using the syringe. This keeps the user's hand away from the needle during uncapping and recapping. The cap of the capped needle is placed in the NO-POKES™ . The "wax-like" substance in the NO-POKES™ holds the cap securely while the operator uses the needle. After the procedure, while the cap is secured in the NO-POKES™, the operator inserts the needle back into the cap without exposing his/her hand to the needle. The NO-POKES™ container has an adhesive on the base to hold it to the desired surface while in use.
    Device Description
    NO-POKES™ is a disposable needle recapping aid that helps prevent recapping injury by providing repository for the needle cap (other than the user's hand) in which to place the cap while using the syringe. This keeps the user's hand away from the needle during uncapping and recapping. The cap of the capped needle is placed in the NO-POKES™ . The "wax-like" substance in the NO-POKES™ holds the cap securely while the operator uses the needle. After the procedure, while the cap is secured in the NO-POKES™, the operator inserts the needle back into the cap without exposing his/her hand to the needle. The NO-POKES™ container has an adhesive on the base to hold it to the desired surface while in use.
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    K Number
    K965248
    Device Name
    BEMIS TWO GALLON SHARPS CONTAINER
    Manufacturer
    BEMIS MFG. CO.
    Date Cleared
    1997-02-14

    (72 days)

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

    BEMIS MFG. CO.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Not Found
    Device Description
    The Demis Two Gallon Sharps Containers are designed for use in areas with controlled access such as labs and pharmacies. They contain features for both temporary and final closure. The Bemis Two Gallon Sharps Containers have a volume of 6 qt. and weigh 1 lb. 2 oz. with dimensions of 8.5"II x 11.5"W x 7.6"D. Two Gallon Sharps Containers are injection molded of polypropylene plastic and are available in translucent red and beige. These containers are NOT reusable. Bemis Two Gallon Sharps Containers are puncture resistant with integral sidewalls and bottom and have a typical wall thickness of .070". The containers are leakproof on the sides and bottom. The Two Gallon Sharps Containers are labeled with the Biohazard warning symbol that is 1½" in height. The label color is orange-red, with lettering and symbol in contrasting color in accordance with OSIIA regulations. The labels are attached directly to the conor in accordance will of a promanent adhesive. The labels boldly indicate fill level of shree-quarter capacity. Bemis Two Gallon Sharps Containers are translucent with clear lids, therefore, allowing visibility at all levels. The Demis Two Gallon Sharps Container is designed for use in areas with controlled access. There is no limitation to hand access for this container as the opening is designed to accept other objects such as butterfly needles, test tubes and vials. Following final closure, the container remains closed during normal handling. There are no features to bend, break, or shear the needle. The lid also incorporates a "needle key" which can be used to unscrew needles from blood collection tube holders. Two Gallon Sharps Containers lock on wall mounted brackets. A key that is unique to this bracket is used to unlock containers from the bracket. The containers are shipped in two pieces and require assembly by the user. Instructions are included in every case.
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    K Number
    K964858
    Device Name
    BEMIS TWO GALLON CHEMOTHERAPY CONTAINER
    Manufacturer
    BEMIS MFG. CO.
    Date Cleared
    1997-02-11

    (69 days)

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

    BEMIS MFG. CO.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Bemis Two Gallon Chemotherapy Container is a sharps disposal container. It is intended for the safe disposal of needles, syringes, and other chemotherapy waste in areas with controlled access. These areas, as defined by OSHA regulations 29 CFR 1910.1030 and 29 CFR 1910.1030, include nurse's stations, oncology, pharmacies, and chemotherapy treatment rooms.
    Device Description
    The Bemis Two Gallon Chemotherapy Containers are designed for use in areas with controlled access, such as nurse's stations, oncology, pharmacies, and chemo treatment rooms. They feature a gasketed lid and screw-on plastic cap. The containers have a volume of 6 qt. and weigh 1 lb. The containers are injections of polypropylene plastic and are available in translucent white. These containers are NOT reusable. Bemis Two Gallon Chemotherapy Containers are puncture resistant with integral wall thickness of .070". The containers are leakproof on the sides and bottom. The lids are gasketed to guard against spills. The containers are labeled with the Biohazard warning symbol that is 1½" in height. The label color is orange-red and yellow, with lettering and symbol in contrasting color in accordance with OSHA regulations. The labels are attached directly to the surface of the container by a permanent adhesive. The labels boldly indicate fill level of three-quarter capacity. Bemis Two Gallon Chemotherapy Containers are translucent white, therefore, allowing visibility of fill level. The Bemis Two Gallon Chemotherapy Container is designed for use in areas with controlled access. The opening is designed to accept other objects related to hand access for this container as the opening is designed to accept other objects related to hand access for this container as the container remains closed during normal handling. The container should be stable in it's upright position when toppled to 20 degrees, and contents should not spill out when toppled. Containers, when in the final closure position and dropped from a distance of 24 inches, remain intact. There are no features to bend, break, or shear the needle. Two Gallon Chemotherapy Containers can be used freestanding or locked on wall mounted brackets. A key that is unique to this order is required to access and unlock containers from mounted brackets. The containers require assembly by the user. Instructions are included in every case.
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    K Number
    K960525
    Device Name
    BEMIS ONE QUART PHLEBOTOMY CONTAINER (PART NUMBER 100)
    Manufacturer
    BEMIS MFG. CO.
    Date Cleared
    1996-03-28

    (52 days)

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

    BEMIS MFG. CO.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Bemis One Quart Phlebotomy Container is a sharps disposal container. It is intended for the safe disposal of needles and syringes in areas with or without controlled access. They are typically used in patient rooms, nurse's stations, doctors' and dentists' offices and on med carts.
    Device Description
    The One Quart Phlebotomy Container has a volume of 1.0 gt. and weigh .0.2 1b (3.2oz.) with dimensions of 8 "H x 4.3"W x 4.3"D. One Quart Phlebotomy Containers are injection molded with polypropylene plastic in translucent red. These products are typically a .. 970" wall thickness. The One Quart Phlebotomy containers are NOT reusable. The One Quart Phlebotomy Containers are puncture-resistant, injection-molded containers with integral sidewalls and bottom. They are leakproof on the sides and bottom. They are labeled with the Biohazard warning symbol. The label color is orange-red, with lettering and symbol in contrasting color in accordance with OSHA regulations. The labels are attached directly to the surface of the container by a permanent adhesive. The One Quart Phlebotomy Container is secured to a tray or table top in an adhesive-backed injection molded plastic base. There are no features to bend, break, or shear the needle. The lid incorporates a "needle key" which can be used to unscrew needles from blood collection tube holders. After blood collection, the needle is inserted into the slotted opening and slid forward until firmly seated, and turned to unscrew the needle from the tube holder. The lid has two openings: one intended to accommodate blood tube needles only and the other, larger opening to accept larger sharps such as butterfly needles. Both openings have covers that may be temporarily closed during transportation. Each cover also has a tab that is inserted in slots for final locking closure for disposal.
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