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510(k) Data Aggregation

    K Number
    K182078
    Device Name
    MiniCollect K2E K2EDTA Tubes
    Manufacturer
    Greiner Bio-One NA Inc.
    Date Cleared
    2019-01-25

    (176 days)

    Product Code
    JKA
    Regulation Number
    862.1675
    Why did this record match?
    Applicant Name (Manufacturer) :

    Greiner Bio-One NA Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    MiniCollect® K2E K2EDTA Tubes are non-evacuated blood collection devices, used to collect, transport, store, and evaluate capillary blood specimens for the following hematology parameters: WBC, RBC, HGB, MCH, MCH, MCHC, Platelets, RDW, Lymphocytes, Neutrophils, Monocytes, Eosinophils and Basophils.
    Device Description
    MiniCollect® Tubes are plastic, non-sterile low sample volume tubes with integrated collection devices. The closure is color-coded to identify the additives which are present in varying concentrations depending on the tube type and stated volumes. The caps of the MiniCollect® Tubes are pierceable for automated instruments with cap-piercing functionalities. The interior of the tube wall is coated with dipotassium EDTA binds calcium ions thus blocking the coagulation cascade. Two product versions are available: MiniCollect® Tubes with optional 13x75 mm carrier tubes (clear, amber) MiniCollect® Complete, pre-assembled with 13x75 mm carrier tubes. The product is to be used by appropriately trained healthcare professionals in accordance with these instructions.
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    K Number
    K180545
    Device Name
    VACUETTE SAFELINK Holder with male luer lock
    Manufacturer
    Greiner Bio-One NA Inc.
    Date Cleared
    2018-05-21

    (81 days)

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

    Greiner Bio-One NA Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The VACUETTE® SAFELINK Holder with male luer lock is for use in blood collection procedures in combination with devices with a female luer port.
    Device Description
    The VACUETTE® SAFELINK Holder with male luer lock is a sterile, single-use, non-invasive device, which consists of a cylinder made from polypropylene plastic with a centric molded male luer lock at the top. The centric location of the male luer lock is to facilitate the connection to non-needle devices with a female luer port. A stainless steel needle with a sleeve is bonded to the inside of the holder to facilitate blood draw by puncturing the cap of an attached blood collection device. The sleeve is made from Synthetic Polyisoprene Compound.
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    K Number
    K163436
    Device Name
    Greiner Vacuette Urine Count and Culture, Mannitol tube
    Manufacturer
    GREINER BIO-ONE NA INC.
    Date Cleared
    2017-03-06

    (89 days)

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

    GREINER BIO-ONE NA INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Greiner Vacuette Urine Count and Culture, Mannitol tube is a urine stabilization device intended for collection, transport and storage of urine for bacterial and yeast culture. Urine samples collected in the Greiner Vacuette Urine Count and Culture, Mannitol tube can be stored at 20-25°C for up to 48 h prior to culture. This device is intended for professional use only.
    Device Description
    Vacuette Urine CCM tubes are tubes made of PET with a pre-defined vacuum to exact draw volumes. They are fitted with yellow Vacuette Safety Caps. The tube interior is sterile. The evacuated tube contains a fine particle granulate stabilizer to preserve the urine sample at 20-25°C for up to 48 hours. The stabilizer helps to preserve and protect the level of bacteria at collection and maintain typically formed elements in urine sediment.
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    K Number
    K160532
    Device Name
    Greiner Holdex
    Manufacturer
    GREINER BIO-ONE NA INC.
    Date Cleared
    2016-11-03

    (251 days)

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

    GREINER BIO-ONE NA INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The HOLDEX® Single-Use Holder PP is for use in venous blood collection procedures in combination with blood collection devices with a female luer port.
    Device Description
    The Greiner HOLDEX Single-Use Holder PP is a disposable plastic holder, which consists of a cylinder made from polypropylene plastic with an off-center molded male luer at the top. The off-center location of the male luer is to facilitate venipuncture when using luer needles. A stainless steel needle with a sleeve is bonded to the inside of the holder to facilitate blood draw by puncturing the cap of an attached blood collection device. The sleeve is made from Synthetic Polyisoprene Compound.
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