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510(k) Data Aggregation

    K Number
    K220739
    Device Name
    Disposable Urine Collection Tube
    Manufacturer
    Zhejiang Gongdong Medical Technology Co., Ltd.
    Date Cleared
    2022-11-17

    (248 days)

    Product Code
    JSM, LIO
    Regulation Number
    866.2390
    Why did this record match?
    Applicant Name (Manufacturer) :

    Zhejiang Gongdong Medical Technology Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Disposable Urine Collection Tube is intended for the collection, transport and preservation of urine specimens from the collection site to the testing laboratory, urine specimens are processed using standard clinical laboratory operating procedures for the cultivation of uropathogenic bacteria and yeasts.
    Device Description
    The Disposable Urine Collection Tubes for the collection, transport and preservation system consist of a safety rubber plug, a plastic cap and boric acid as an additive inside the tube. The tube is made of Polyethylene terephthalate (PET) and the safety plug is made of butvl-rubber while the disposable cap is made of Polyethylene (PE). The disposable tube device sustains the viability of organisms during transport for up to 48 hrs. at 2-4°C and 22-25°C.There are two main tube types (round and conical bottom), and four configurations by volume of urine for the round bottom tubes (4 ml, 7 ml, 8 ml, 10 ml). The conical bottom tubes only have one configuration by volume (8 ml). Each volume is available in yellow and white caps.
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