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510(k) Data Aggregation

    K Number
    K972705
    Device Name
    RESHEATHER DEVICE-METAL OR PLASTIC, RESHEATER/ NEEDLE HOLDER DEVICE-PLASTIC
    Manufacturer
    SAGE PRODUCTS, INC.
    Date Cleared
    1998-04-30

    (283 days)

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

    SAGE PRODUCTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The plastic and metal resheathers are placed at or near the point of use and allow one handed needle resheathing. The plastic and foam resheather/needle holder is placed at or near the point of use and allows one handed needle resheathing or allows the user to place the needle into the foam to temporarily hold it prior to disposal.
    Device Description
    The Resheathing Devices are constructed of metal or placed securely at or near the point of use and enable the healthcare worker to single handedly recap, or hold a hypodermic syringe, blood. collection device, or IV administration set.
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    K Number
    K980490
    Device Name
    SAGE PRODUCTS INC, SHARPS DISPOSAL CONTAINERS WITH SCREW TOP CAPS
    Manufacturer
    SAGE PRODUCTS, INC.
    Date Cleared
    1998-02-24

    (15 days)

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

    SAGE PRODUCTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Sage Sharps Disposal Containers with Screw Top Caps is intended for single use disposal of used or contaminated medical sharps, including, but not limited to, hypodermic needles, syringes, lancets, and Blood Needles. The containers can be used in variety of healthcare settings. The containers are suitable for physician offices, dental offices, laboratories, home health and other generators of medical waste. The containers are also appropriate for patient room applications.
    Device Description
    The Sage Products, Inc. Sharps Containers with Screw Top Caps are molded, single use, non-sterile, disposable, sharps disposal containers. The containers are designed to hold used sharps such as angio-caths, blood needles, lancets and various sized syringes. Various sizes of the container will be offered to meet customer disposal needs. The shape of the container will either be rectangular or circular depending upon its size. The only access to the container is through the screw top closure. Products will be available with or without a neck insert at the opening to limit the ability of the sharps to exit the container after disposal.
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    K Number
    K973911
    Device Name
    2 GALLON ALTERNATE CARE SHARPS CONTAINER
    Manufacturer
    SAGE PRODUCTS, INC.
    Date Cleared
    1997-10-29

    (15 days)

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

    SAGE PRODUCTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Sage 2 Gallon Alternate Care Sharps Container is intended for single use disposal of used or contaminated medical sharps, including, but not limited to, hypodermic needles, syringes, lancets, IV Cassettes, and Blood Needles. Sage 2 Gallon Alternate Care Sharps Containers are used in both clinical and nonclinical settings.
    Device Description
    The Sage 2 Gallon Alternate Care Sharps Container is an injection molded, single use, non-sterile, disposable, sharps disposal container. The product is designed to hold sharps such as angio-caths, blood needles, lancets and various sized syringes and non-sharps such as drug infusion cassettes.
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    K Number
    K972279
    Device Name
    SHARPS SHUTTLE
    Manufacturer
    SAGE PRODUCTS, INC.
    Date Cleared
    1997-08-29

    (72 days)

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

    SAGE PRODUCTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Sharps Shuttle and Sharp Shuttle with Locking Mechanism are single use, Sharps transport containers intended for use in any setting where standard sharps containers are not conveniently accessible, such as EMS, home health care, etc..
    Device Description
    The Sharps Shuttle and Sharps Shuttle with Locking Mechanism are injection or blow molded, single use, non-sterile, disposable, sharps transport containers intended for use in any setting where standard sharps containers are not conveniently accessible, such as EMS, home health care, etc. The Sharps Shuttles may be viewed as a portable sharps containment device that provides an alternative to the procedure of resheathing a needle with its original protective cover which is not a recommended practice or disposing of the sharp in a non-sharps container. The products are designed to hold sharps such as angio-caths, blood needles, lancets and small syringes. The container is cylindrical for rigidness and has a conical taper. The product body is non colored translucent plastic and is approximately 6 inches long by 1 inch in diameter. The cap is red opaque plastic with a hinged cap which when snapped closed contains the biohazardous sharps for safe conveyance. Locking and non locking versions are available. Both versions have a temporary closure which can be reopened for the placement of additional sharps prior to terminal disposal. In addition to the temporary closure, the locking Sharps Shuttle with Locking Mechanism can be permanently locked by engaging the locking tab. Each unit is individually labeled with a biohazard label. Sharps Shuttles are available singly or packaged in a dispenser with an attached carrying handle for easy transport of unused containers. The dispenser is available for the storage of the device prior use. The dispenser does not function as an accessory for use, nor, is it intended to transport containers with biohazardous waste.
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    K Number
    K970135
    Device Name
    NITRILE GLOVES
    Manufacturer
    SAGE PRODUCTS, INC.
    Date Cleared
    1997-08-25

    (222 days)

    Product Code
    LZC
    Regulation Number
    880.6250
    Why did this record match?
    Applicant Name (Manufacturer) :

    SAGE PRODUCTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    A medical glove worn on the hand of a healthcare worker and similar personnel to prevent contamination between healthcare personnel and patient. In addition, this glove is worn for the protection of the wearer against exposure to chemotherapeutic agents.
    Device Description
    8 mil thick, Non Sterile, fitted or ambidextrous, Nitrile gloves with beaded cuff extending beyond the wrist.
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    K Number
    K972302
    Device Name
    POCKET COUNT OR SAFETCOUNT
    Manufacturer
    SAGE PRODUCTS, INC.
    Date Cleared
    1997-07-25

    (36 days)

    Product Code
    LWH
    Regulation Number
    880.2740
    Why did this record match?
    Applicant Name (Manufacturer) :

    SAGE PRODUCTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Containment and Counting of Sponges in the Operating Room or a hospital setting.
    Device Description
    Pocket Count: Transparent, compartmentalized, disposable bag which allows visual confirmation of sponge count and visual estimate of absorbed fluid. Pocket Count provides partial containment of contaminated sponges, thereby, decreasing worker exposure to contents. SafeTCount: Transparent, disposable hand shaped covering which is used to collect sponges. When the covering is turned inside out it contains the contaminated sponges thereby decreasing worker exposure to contents. The SafeTCount allows visual confirmation of sponge count and visual estimate of absorbed fluid.
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    K Number
    K964168
    Device Name
    PROCEDURE SPECIFIC KITS
    Manufacturer
    SAGE PRODUCTS, INC.
    Date Cleared
    1997-03-03

    (137 days)

    Product Code
    FXX
    Regulation Number
    878.4040
    Why did this record match?
    Applicant Name (Manufacturer) :

    SAGE PRODUCTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Combinations of products for the convenience and personal protection of the end user from blood, body fluids and chemicals while conducting specific procedures. The kits will include disposable, single use items for blood, drug or chemical spill clean up, drug preparation and/or drug administration.
    Device Description
    Procedure Specific kits are non-sterile kits that bundle or package together combinations of products for the convenience of the user. This saves the end user the time and effort of retrieving the individual products each time a procedure is performed. Kit components are purchased as released finished goods in finished package form. To assemble a kit, individual products are selected, sealed in a polybag or other suitable container, and labeled with a contents label. If the finished package form is more than one unit, Sage will remove the number of units specified for the kit being assembled. The item will be repackaged in the kit without compromising the integrity of the product. There is no reprocessing of any of the components that would compromise an original intended use or alter its safety or effectiveness.
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    K Number
    K963986
    Device Name
    STP SYSTEM PVA WITH ZINC
    Manufacturer
    SAGE PRODUCTS, INC.
    Date Cleared
    1996-11-08

    (35 days)

    Product Code
    LIO
    Regulation Number
    866.2900
    Why did this record match?
    Applicant Name (Manufacturer) :

    SAGE PRODUCTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Collection, transport, preservation and preparation of stool specimens containing intestinal parasites for microscopic examination
    Device Description
    The product contains two conical shaped centrifuge tubes. One tube contains Polyvinyl Alcohol with Zinc and the other 10% Buffered Formalin. A stand is provided to keep the tubes in the upright position. Both tubes have a spoon contained within the tube which is attached to the cap. The cap/spoon is removed and used to obtain a sample of the stool specimen. The sample is placed into the centrifuge tubes and the cap/spoon assembly is securely closed. The collection tubes are shaken causing the mixing balls to disrupt the specimen allowing complete coverage of the specimen with the fixative. The sample in PVA can be used for permanent staining techniques. The tube with the 10% Buffered Formalin also contains an integral filter which separates large debris from the specimen facilitating concentration of the specimen for wet mount examination. The product is contained in a bag labeled with the biohazard symbol which can be used for transport of the tubes containing samples.
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    K Number
    K964026
    Device Name
    STP SYSTEM - SAF
    Manufacturer
    SAGE PRODUCTS, INC.
    Date Cleared
    1996-11-07

    (31 days)

    Product Code
    LIO
    Regulation Number
    866.2900
    Why did this record match?
    Applicant Name (Manufacturer) :

    SAGE PRODUCTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Collection, transport, preservation and preparation of stool specimens containing intestinal parasites for microscopic examination
    Device Description
    The product is comprised of a conical shaped centrifuge tube containing Sodium Acetate-Acetic Acid-Formalin (SAF) solution. A stand is provided to keep the tube in the upright position. A spoon is attached to the cap and contained within the tube. The cap/spoon is removed and used to obtain a sample of the stool specimen. The sample is placed into the centrifinge tube and the cap/spoon assembly is securely closed. The collection tube is shaken causing the mixing balls to disrupt the specimen allowing complete coverage of the specimen with the fixative. The tube also contains an integral filter which separates large debris from the specimen and facilitates concentration of the specimen. The sample can be used for permanent staining, concentration, and/or wet mount procedures. The product is contained in a bag labeled with the biohazard symbol which can be used for transport of the tube containing the sample.
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    K Number
    K964027
    Device Name
    STP SYSTEM-PVA WITH MERCURY
    Manufacturer
    SAGE PRODUCTS, INC.
    Date Cleared
    1996-11-01

    (25 days)

    Product Code
    LIO
    Regulation Number
    866.2900
    Why did this record match?
    Applicant Name (Manufacturer) :

    SAGE PRODUCTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Collection, transport, preservation and preparation of stool specimens containing intestinal parasites for microscopic examination
    Device Description
    The product contains two conical shaped centrifuge tubes. One tube contains Polyvinyl Alcohol with Mercury and the other 10% Buffered Formalin. A stand is provided to keep the tubes in the upright position. Both tubes have a spoon contained within the tube which is attached to the cap. The cap/spoon is removed and used to obtain a sample of the stool specimen. The sample is placed into the centrifyge tubes and the cap/spoon assembly is securely closed. The collection tubes are shaken causing the mixing balls to disrupt the specimen allowing complete coverage of the specimen with the fixative. The sample in PVA can be used for permanent staining techniques. The tube with the 10% Buffered Formalin also contains an integral filter which separates large debris from the specimen facilitating concentration of the specimen for wet mount examination. The product is contained in a bag labeled with the biohazard symbol which can be used for transport of the tubes containing samples.
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