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510(k) Data Aggregation

    K Number
    K161180
    Device Name
    Oak Ridge Products Sharps Containers
    Manufacturer
    OAK RIDGE PRODUCTS, LLC
    Date Cleared
    2016-06-09

    (43 days)

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

    OAK RIDGE PRODUCTS, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Oak Ridge Products Sharps containers are a single-use, disposable, non-sterile containers intended to be used for healthcare purposes for safe disposal of hazardous sharps such as hypodermic needles, syringes, lancets and blood needles. The target population is for trained healthcare professionals. All the containers are intended to be used in areas where there is no unsupervised patient access.
    Device Description
    The Oak Ridge Products Sharps Containers are of injection molded polypropylene plastic, designed for a single-use by healthcare professionals. No part of the container is intended to come in contact with patients. The containers are designed to be puncture resistant. leak resistant on the sides and bottom, impact resistant, closable and stable. Large access openings allow for disposal of sharps with one hand use. The plastic used for the sharps containers are of a similar chemical formula as the comparable predicate devices and many of the sharps objects that will be placed within the container such as plastic syringe bodies. These containers are suitable for a terminal disposal by incineration and all materials used are fully consumable during incineration. The Oak Ridge Products Sharps Containers are made of three parts (a base, a lid, and a closure) that form a single unit. The lid and closure come preassembled with the base not attached. Parts are nested to together to reduce storage and shipping requirements. The healthcare facility performs the final assembly on-site by snapping the lid to the base. Lids and closures are uncolored translucent material allowing for a visual determination of fill level. The base is made from a high strength material to support the capacity of the container. The recommended fill level is engraved onto the plastic and corresponds to the fill level line on the product identification label.
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    K Number
    K141759
    Device Name
    OAK RIDGE PRODUCTS MULTI-PURPOSE SHARPS CONTAINERS
    Manufacturer
    OAK RIDGE PRODUCTS, LLC
    Date Cleared
    2014-10-24

    (115 days)

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

    OAK RIDGE PRODUCTS, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Oak Ridge Products Sharps containers are a single-use, disposable, non-sterile containers intended to be used for healthcare purposes for safe disposal of hazardous sharps such as hypodermic needles, syringes, lancets and blood needles. The target population is for trained healthcare professionals. The containers 0330-150S and 0370-1500 are intended to be used in areas where there is no unsupervised patient access. The 0330-150M container with the counterbalanced closure is intended to be used in areas that have unsupervised patient access.
    Device Description
    The Oak Ridge Products Sharps Containers are of injection molded polypropylene plastic, designed for a single-use by health care professionals. No part of the container is intended to come in contact with patients. The containers are designed to be puncture resistant. leak resistant on the sides and bottom, impact resistant, closable and stable. Large access openings allow for disposal of sharps with one hand use. The plastic used for the sharps containers are of a similar chemical formula as the comparable predicate devices and many of the sharps objects that will be placed within the container such as plastic syringe bodies. These containers are suitable for a terminal disposal by incineration and all materials used are fully consumable during incineration. The Oak Ridge Products Sharps Containers are made of three parts (a base, a lid, and a closure) that form a single unit. The lid and closure come preassembled with the base not attached. Parts are nested to together to reduce storage and shipping requirements. The health care facility performs the final assembly on-site by snapping the lid to the base.
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    K Number
    K130281
    Device Name
    OAK RIDGE PRODUCTS SHARP CONTAINER
    Manufacturer
    OAK RIDGE PRODUCTS, LLC
    Date Cleared
    2013-06-21

    (136 days)

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

    OAK RIDGE PRODUCTS, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Oak Ridge Products Sharps containers are single-use, disposable, non-sterile containers intended to be used for healthcare purposes for safe disposal of hazardous sharps such as hypodermic needles, syringes, lancets and blood needles. The target population is for trained healthcare professionals. The 1 quart Phlebotomy container is intended to be used with an appropriate mounting device. The 5.4 quart is intended to be used with an appropriate mounting device. The 2 gallon container is intended to be used in areas where there is no unsupervised patient access.
    Device Description
    The Oak Ridge Products Sharps Containers are an injection molded polypropylene plastic designed for a single-use. The containers are puncture resistant, leak resistant on the sides and bottom, closable and stable. The products have engraved maximum fill lines on the containers and instructions for locking the container closed. Labels are white with black text and a black bio-hazard symbol printed on an orange-red background. Labels are adhered to the containers at the time of manufacture with the fill line warning matching the engraved fill line on the container. The Oak Ridge Products Sharps Containers are made of three parts (a base, a lid, and a closure) that form a single unit. Parts are nested together to reduce storage and shipping requirements. The bases are offered in natural (translucent) or colored (red). These are available in three sizes; 1) 1 quart Phlebotomy, 2) 5.4 quart for Patient room and 3) 2 gallon containers. Lids and closures are uncolored translucent material. The translucent nature of the product allows for a visual determination of content level.
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