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510(k) Data Aggregation

    K Number
    K102741
    Device Name
    ENTERAL FEEDING BAG AND SETS
    Manufacturer
    SHANDONG WEIGAO GROUP MEDICAL POLYMER CO.,LTD.
    Date Cleared
    2011-11-08

    (412 days)

    Product Code
    KNT
    Regulation Number
    876.5980
    Why did this record match?
    Applicant Name (Manufacturer) :

    SHANDONG WEIGAO GROUP MEDICAL POLYMER CO.,LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Enteral Feeding Bag and Set is intended to delivery, via a feeding pump, liquid nutrition formulas to an enteral access device (e.g. a feeding tube).
    Device Description
    The proposed device, Enteral Feeding Bag and Set, has two models: one is enteral feeding set integrated with bag, the other is an individual enteral feeding set with a puncture needle which can be used along with other pre-filled formula container. Other components include: Roller Clamp, which is used to adjust the feeding rate; Tubings, which are used to connected components; Drip Chamber, which is intended for the user to observe the feeding condition; Echelon Fitting, which is a non-luer fitting, to connect Enteral Access Device. This fitting is provided to avoid mis-connection with I.V. devices.
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    K Number
    K102328
    Device Name
    BLUNT FILL NEEDLE AND BLUNT PLASTIC CANNULA
    Manufacturer
    SHANDONG WEIGAO GROUP MEDICAL POLYMER CO.,LTD.
    Date Cleared
    2011-05-13

    (269 days)

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

    SHANDONG WEIGAO GROUP MEDICAL POLYMER CO.,LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The blunts include two models, which are blunt fill needle and blunt plastic cannula. The blunt fill needle is used in conjunction with a syringe to penetrate the vial/ampoules stopper intended for injection or aspiration of fluid. The blunt plastic cannula is used in conjunction with a syringe to access the pre-slit septum covering injection sites on I.V. System intended for injection or aspiration of fluid.
    Device Description
    The blunts include two models, which are blunt fill needle and blunt plastic cannula. The blunt fill needle is an 18G stainless needle tube with a luer slip hub. It is used to penetrate the vial and/or ampoules stopper intended for injection or drawl fluid. The hub is a luer slip female conical fitting, which can be connected to the luer slip male conical fitting on the syringe. It is not intended to access the injection site on I.V. System. The blunt plastic cannula is a molded plastic blunt tipped cannula to penetrate pre-slit septum injection site on I.V. Safety Systems, which is designed for penetration with needleless I.V. access device, intended for injection and/or aspiration of fluid. It also has a luer slip female conical fitting, which can be connected to the luer slip male conical fitting on the syringe to be filled. The blunt plastic cannula is used to replace hypodermic needles to prevent from the unintended injury by metal needle. These two products can be sold together in one immediate package or respectively in separate immediate packages.
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    K Number
    K081241
    Device Name
    WEIGAO EMPTY CARTRIDGE SYRINGE
    Manufacturer
    SHANDONG WEIGAO GROUP MEDICAL POLYMER CO.,LTD.
    Date Cleared
    2008-09-08

    (130 days)

    Product Code
    FMF
    Regulation Number
    880.5860
    Why did this record match?
    Applicant Name (Manufacturer) :

    SHANDONG WEIGAO GROUP MEDICAL POLYMER CO.,LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Weigao Disposable Empty Cartridge Syringe is intended for use in the withdrawal and administration of fluid in accordance with the best judgment of the physician.
    Device Description
    The subject device of Weigao Disposable Empty Cartridge Syringe is an empty cartridge syringe that consists of a hollow barrel and a movable plunger. The syringes are designed for manual use. The applicant syringe's main components are made of glass.
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    K Number
    K072739
    Device Name
    JIERUI SYRINGES AND NEEDLES
    Manufacturer
    SHANDONG WEIGAO GROUP MEDICAL POLYMER CO.,LTD.
    Date Cleared
    2008-03-21

    (176 days)

    Product Code
    MEG, FMF, FMI
    Regulation Number
    880.5860
    Why did this record match?
    Applicant Name (Manufacturer) :

    SHANDONG WEIGAO GROUP MEDICAL POLYMER CO.,LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Sterile Hypodermic Syringe for Single Use With/without needle is intended to be used for medical purposes to inject fluid into or withdraw fluid from body. The sterile Insulin Syringe for single use with needle is a device intended for medical purposes for the manual aspiration of insulin, and for the injection of insulin into parts of the body below the surface skin. The Retractable Auto-Disable Syringe for single use with/without needle is intended to be used for medical purposes to inject fluid into or withdraw fluid from body. Its secondary intended use is to retract inside the safety barrel, contain the contaminated needle and aid in the prevention of accidental needle stick injuries. The Sterile Hypodermic Needle for single use is intended for use with syringes and injection devices for general purpose fluid injection/aspiration.
    Device Description
    | Device Name | Intended Use | Nozzel | Volume | Material | Remark | |-------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------|---------------------------------------------------------|--------------------|---------------------------| | Sterile Hypodermic<br>Syringe for single use | The Sterile Hypodermic Syringe for Single Use<br>With/without needle is intended to be used for medical<br>purposes to inject fluid into or withdraw fluid from<br>body. | Luer Slip | 1,2,3,5,10,20,30,50,100<br>(ml) | PP | With or Without<br>Needle | | Sterile Insulin<br>Syringe for single use | The sterile Insulin Syringe for single use with needle is<br>a device intended for medical purposes for the manual<br>aspiration of insulin, and for the injection of insulin into<br>parts of the body below the surface skin. | Fixed | 0.5,1<br>(ml) | PP | With Fixed Needle | | Retractable<br>Auto-Disable Syringe<br>for single use | The Retractable Auto-Disable Syringe for single use<br>with/without needle is intended to be used for medical<br>purposes to inject fluid into or withdraw fluid from<br>body. Its secondary intended use is to retract inside the<br>safety barrel, contain the contaminated needle and aid in<br>the prevention of accidental needle stick injuries. | Luer Lock | 3,5,10<br>(ml) | PP | With or Without<br>Needle | | Sterile Hypodermic<br>Needle for single use | The Sterile Hypodermic Needle for single use is<br>intended for use with syringes and injection devices for<br>general purpose fluid injection/aspiration | Luer Slip<br>Luer Lock | 16G,18G,19G,20G,<br>21G,22G,23G,24G,<br>25G,26G,27G,29G | Stainless<br>Steel | |
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    K Number
    K073127
    Device Name
    BLOOD COLLECTION NEEDLE, MODEL 20G 21G 22G
    Manufacturer
    SHANDONG WEIGAO GROUP MEDICAL POLYMER CO.,LTD.
    Date Cleared
    2007-12-20

    (44 days)

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

    SHANDONG WEIGAO GROUP MEDICAL POLYMER CO.,LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Blood Collection Needles is designed for use in the daily blood collection routine when delegated by a qualified practitioner.
    Device Description
    Blood collection needle is a sterile and disposable medical device. It is consist of a puncturing needle which is punctured into vein, a bottle needle which is insert to the blood collection bottle to collect blood, a needle holder which connects the puncturing needle and bottle needle, two needle caps which protect puncturing needle and bottle needle and a latex cover to protect bottle needle.
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