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510(k) Data Aggregation

    K Number
    K014104
    Device Name
    VACUETTE EDTA K2 TUBES
    Manufacturer
    GREINER VACUETTE NORTH AMERICA, INC.
    Date Cleared
    2002-02-01

    (50 days)

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

    GREINER VACUETTE NORTH AMERICA, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The VACUETTE® EDTA K2 tube provides a means for collection, processing and transportation of an undiluted plasma specimen in a closed evacuated system. The tube contains spray-dried EDTA, yielding a ratio of 1.8mg/mL of blood when the evacuated tube is filled correctly to its fill volume. The VACUETTE® EDTA K2 tube is used for plasma preparation and is made of plastic for the collection of venous blood which upon centrifugation separates undiluted plasma for use in molecular diagnostic test methods (such as but not limited to PCR - Polymerase Chain Reaction), or other procedures where an undiluted plasma specimen is required as determined by the laboratory.
    Device Description
    The VACUETTE® EDTA K2 Tube is used for plasma preparation and is made of plastic for the collection of venous blood which upon centrifugation separates undiluted plasma for use in molecular diagnostic test methods (such as but not limited to PCR - Polymerase Chain Reaction), or other procedures where an undiluted plasma specimen is required as determined by the laboratory.
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    K Number
    K012043
    Device Name
    VACUETTE EDTA K2 GEL TUBES
    Manufacturer
    GREINER VACUETTE NORTH AMERICA, INC.
    Date Cleared
    2001-09-24

    (87 days)

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

    GREINER VACUETTE NORTH AMERICA, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The VACUETTE® EDTA K2 Gel tube provides a means for collection, processing and transportation of an undiluted plasma specimen in a closed evacuated system. The tube contains spray-dried EDTA, yielding a ratio of 1.8mg/mL of blood when the evacuated tube is filled correctly to its fill volume, and a gel barrier material. The VACUETTE® EDTA K2 Gel tube is used for plasma preparation and is made of plastic for the collection of venous blood which upon centrifugation separates undiluted plasma for use in molecular diagnostic test methods (such as but not limited to PCR - Polymerase Chain Reaction), or other procedures where an undiluted plasma specimen is required as determined by the laboratory.
    Device Description
    The VACUETTE® EDTA K2 Gel tube provides a means for collection, processing and transportation of an undiluted plasma specimen in a closed evacuated system. The tube contains spray-dried EDTA, yielding a ratio of 1.8mg/mL of blood when the evacuated tube is filled correctly to its fill volume, and a gel barrier material. The VACUETTE® EDTA K2 Gel Tube is used for plasma preparation and is made of plastic for the collection of venous blood which upon centrifugation separates undiluted plasma for use in molecular diagnostic test methods (such as but not limited to PCR - Polymerase Chain Reaction), or other procedures where an undiluted plasma specimen is required as determined by the laboratory.
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    K Number
    K011786
    Device Name
    VACUETTE SAFETY BLOOD COLLECTION SET
    Manufacturer
    GREINER VACUETTE NORTH AMERICA, INC.
    Date Cleared
    2001-07-12

    (34 days)

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

    GREINER VACUETTE NORTH AMERICA, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The VACUETTE® Safety Blood Collection Set is a single-use, sterile, winged blood collection needle bonded to a flexible tubing with a female luer adapter. The VACUETTE® Safety Blood Collection Set is used in routine venipuncture procedures. The winged needle is designed with a safety shield, which can be activated to cover the needle immediately following venipuncture to aid in the protection against accidental needlestick injury. The product is to be used by appropriately trained healthcare professionals only in accordance with these instructions.
    Device Description
    The VACUETTE® Safety Blood Collection Set is a single-use, sterile, winged blood collection needle bonded to a flexible tubing with a female luer adapter. The Winged needle is designed with a safety shield, which can be activated to cover the noodle in houleve inmediately following venipuncture to aid in the protection against accreental in accordance with these instructions. The safety feature is easily operated through the release of a latch mechanism whereby the The Salely leature is easily operator and it is removed from the patient. Once the user slides a wingsu ocatety cover locks in place. This mechanism is substantially needie is covered, the oulony ject® Angel Wing Blood Collection Set. The VACUETTE® Safety Blood Collection Set will be available in 80 configurations to include needle gauge (10 gauge sizes), needle length (2 lengths) and tubing length (4 lengths). The devices are packaged as sterile and are labeled for single use only. There is no ability The devices are pookegoe as ses. The results of biocompatibility data support the to clean and rease theose and include sterility, pyrogenicity and systemic injection testing.
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    K Number
    K003812
    Device Name
    VACUETTE SPEEDY QUICK-RELEASE HOLDER
    Manufacturer
    GREINER VACUETTE NORTH AMERICA, INC.
    Date Cleared
    2001-04-30

    (140 days)

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

    GREINER VACUETTE NORTH AMERICA, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K002777
    Device Name
    VACUETTE WITH PPACK
    Manufacturer
    GREINER VACUETTE NORTH AMERICA, INC.
    Date Cleared
    2000-10-05

    (29 days)

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

    GREINER VACUETTE NORTH AMERICA, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question

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