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510(k) Data Aggregation

    K Number
    K113186
    Device Name
    STERILE INSULIN PEN NEEDLE
    Manufacturer
    SHINA CORP.
    Date Cleared
    2012-04-12

    (167 days)

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

    SHINA CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    ShinaPen® is intended for use with pen injector devices for the subcutaneous injection of insulin.
    Device Description
    The ShinaPen® are designed for use with a pen injector for the subcutaneous injection of insulin. The pen needle consists of a needle, hub, and shield assembly. Blister paper covers primary container. The primary container maintains sterility the of the needle because primary container covers the hub and needle cap with blister paper sealed on the opening hole of primary container. The needle hub can be connected screwed onto the pen. The needle shield is intended to provide physical protection to the needle tube. The ShinaPen® are offered various gauges sizes (29G, 30G, 31G, 32G) and Lengths (4mm, 6mm, 8mm, 12.7mm). These are sterile (Eo gas sterilization), non-toxic, and non-pyrogenic. The pen needles are disposable, single use devices.
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    K Number
    K091167
    Device Name
    SHINA INSULIN SYRINGE-INCLUDING ACCU-SURE INSULIN SYRINGES
    Manufacturer
    SHINA CORP.
    Date Cleared
    2009-08-06

    (106 days)

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

    SHINA CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This device is a hypodermic insulin syringe for subcutaneous injection of insulin.
    Device Description
    Shina Insulin Syringes are designed for the subcutaneous injection of a desired dose of insulin. The syringe has a graduated barrel, a plunger rod and needle/hub assembly. The needle shield is colored orange. The Syringes are available in the following sizes: 1/2cc and 1cc 28 gauge x 1/2" 3/10cc, 1/2cc, and 1cc 29 gauge x ½" 3/10cc, 1/2cc, and 1cc 30 gauge x 1/2" 3/10cc, 1/2cc, and 1cc 30 gauge x 5/16" 3/10cc, 1/2cc, and 1cc 31 gauge x 5/16" These devices operate on the principles of a piston syringe. The syringe fluid path is sterile (EO Gas sterilization), non-toxic, non-pyrogenic, and single use disposable.
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    K Number
    K071947
    Device Name
    VACU-MED BLOOD COLLECTION NEEDLES
    Manufacturer
    SHINA CORP.
    Date Cleared
    2007-10-12

    (91 days)

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

    SHINA CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    VACU-MED® Blood Collection Needles are designed for use in venous blood collection.
    Device Description
    VACU-MED® Blood Collection Needles are manufactured from tubular stainless steel sharpened at both ends that is attached to the hub. The hub is threaded on one side to connect with the needle holder which is used to guide the needle into an evacuated blood collection tube. This end of the needle is the shorter end and is fitted with a protective rubber sleeve and a hard plastic needle cap. The opposite end of the needle is 1" or 1½" for withdrawing blood and is fitted with a color coded hard plastic needle cap. The two needle caps protect the needle and maintain the sterility. The seal between the two needle caps is covered with a perforated paper label that simplifies identification and acts as a seal of integrity. VACU-MED® Blood Collection Needles are a sterile single-use disposable product. The needles are non-toxic and non-pyrogenic, and are available in a variety of combinations of needle sizes (20 to 22 gauge) and needle lengths (1" and 1½").
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