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510(k) Data Aggregation

    K Number
    K122687
    Device Name
    BLOOD CULTURE HOLDER
    Manufacturer
    GREINER BIO-ONE NORTH AMERICA, INC.
    Date Cleared
    2013-01-10

    (128 days)

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

    GREINER BIO-ONE NORTH AMERICA, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Blood Culture Holder is used to fill blood into blood culture bottles and tubes in routine venipuncture procedures. This device is to be used by properly trained healthcare professionals only in accordance with these instructions. The SAFETY Blood Collection Set and/or Blood Collection Set + Blood Culture Holder are used in routine venipuncture procedures. The winged needle of the SAFETY Blood Collection Set is designed with a while shield, which can be activated to cover the needle immediately following blood collection to aid in the protection against accidental needlestick injury. The Blood Culture Holder is used to fill blood into blood culture bottles and tubes.
    Device Description
    The Blood Culture Holder is a single-use, non-sterile, plastic holder with threads which are compatible with male luer adapters. The holder can be used with all VACUETTE® Multiple Sample Luer Adapters and Safety Blood Collection Sets for routine venipuncture into various manufacturers' evacuated blood culture bottles and tubes. It is supplied alone or with the Greiner sterile Safety Blood Collection Set with Luer Adapter. The Blood Culture Holder does not come into contact with the blood specimen. It is an external holder for the Safety Blood Collection Set and the VACUETTE® Multiple Sample Luer Adapter. The Safety Blood Collection Set consists of tubing with a blood collection needle at one end and a female luer at the other. The VACUETTE® Multiple Sample Luer Adapter consists of a male luer at one end and a cannula covered with a sheath. The luer adapter is threaded into the Blood Culture Holder, with the male luer end on the outside and the covered cannula on the inside of the holder barrel. The blood flows through the blood collection needle and tubing of the Safety Blood Collection Set, into the male luer of the VACUETTE® Multiple Sample Luer Adapter, through the luer into the cannula, and into the blood culture tube or holder when punctured by the cannula. The fluid path consists of the Safety Blood Collection Set and the VACUETTE® Multiple Sample Luer Adapter. The Blood Culture Holder never comes into contact with the blood specimen during conditions of use. When the Blood Culture Holder is supplied attached to the Safety Blood Collection Set and the VACUETTE® Multiple Sample Luer Adapter, it undergoes sterilization as part of the entire system because the fluid path must be sterilized. However, when the Blood Culture Holder is provided alone, it is not sterilized and the user attaches their own sterile blood collection needle and luer adapter. The Safety Blood Collection Set with Blood Culture Holder is non-pyrogenic and tested according to ISO-10993-11 rabbit pyrogen test. The devices also are below the limit for endotoxin and tested according to ISO-10993-11 LAL Turbidimetric Method.
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    K Number
    K121908
    Device Name
    SAFETY INFUSION SET
    Manufacturer
    GREINER BIO-ONE NORTH AMERICA, INC.
    Date Cleared
    2012-07-25

    (26 days)

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

    GREINER BIO-ONE NORTH AMERICA, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The VACUETTE® SAFETY Infusion Set is a single-use, sterile, winged blood collection needle bonded to a flexible tubing with a luer connector. The VACUETTE® SAFETY Infusion Set is used for blood collection and/or the short-term infusion of intravenous fluids. 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.
    Device Description
    The Greiner VACUETTE® SAFETY Infusion Set is a single-use, sterile, winged infusion and blood collection needle bonded to flexible tubing with a female luer adapter. The VACUETTE® SAFETY Infusion Set is used for short-term administration of intravenous fluids and/or for blood collection. 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 manufacturer's instructions. It can be used in conjunction with an intravascular administration set or with a syringe or other device in order to administer fluids. The safety feature is easily operated through the release of a latch mechanism whereby the user slides a winged cover over the needle, as it is removed from the patient. Once the needle is covered, the safety cover locks in place. The devices are packaged as sterile and are labeled for single use only. There is no ability to clean and reuse these devices because the safety feature cannot be deactivated without bending the needle and rendering it unusable.
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    K Number
    K113505
    Device Name
    VACUETTE QUICKSHIELD WITH SNAPPY TUBE HOLDER
    Manufacturer
    GREINER BIO-ONE NORTH AMERICA, INC.
    Date Cleared
    2012-02-17

    (81 days)

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

    GREINER BIO-ONE NORTH AMERICA, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The VACUETTE® QUICKSHIELD with SNAPPY Tube Holder is to be used together only with VACUETTE® Blood Collection Needles and VACUETTE® Blood Collection Tubes as a system in routine venipuncture procedures. These devices are to be used by properly trained healthcare professionals only in accordance with these instructions.
    Device Description
    The VACUETTE® QUICKSHIELD with SNAPPY Tube Holder is a non-sterile single-use plastic tube holder. It 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. VACUETTE® QUICKSHIELD with SNAPPY Tube Holder helps secure VACUETTE® tubes in place during collection. Note: Always follow tube manufacturer's specimen collection instructions for holding tube in place to ensure a complete vacuum draw. These devices are to be used by properly trained healthcare professionals only in accordance with these instructions.
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    K Number
    K103041
    Device Name
    VACUETTE BLOOD COLLECTION TUBE WITH LITHIUM HEPARIN AND GEL SEPARATOR
    Manufacturer
    GREINER BIO-ONE NORTH AMERICA, INC.
    Date Cleared
    2010-11-09

    (26 days)

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

    GREINER BIO-ONE NORTH AMERICA, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    VACUETTE Blood Collection Tubes with Lithium Heparin and Gel Separator are used to collect, transport and process blood for testing plasma in the clinical laboratory.
    Device Description
    VACUETTE Evacuated Blood Collection Tubes are plastic tubes with a pre-defined vacuum for exact draw volumes. They are fitted with color coded VACUETTE Safety Caps (green for heparin tubes). The tubes, additive concentrations, volumes of liguid additives, and their permitted tolerances, as well as the blood-to-additive ratio, are in accordance to the requirements and recommendations of the international standards ISO 6710 "Single use containers for venous blood specimen collection" and the Clinical and Laboratory Standards Institute's Approved Standards (CLSI). VACUETTE Evacuated Blood Collection Tubes with Lithium Heparin and Gel contain a barrier gel in the tube. The specific gravity of this material lies between the blood cells and plasma. During centrifugation the gel barrier moves upward, where it forms a stable barrier separating the plasma from cells. Plasma may be aspirated directly from the collection tube, which eliminates the need for transfer to another container. The changes for the VACUETTE Evacuated Blood Collection Tube with Lithium Heparin and Gel are in the Instructions for Use (IFU): - Recommended g-force (relative centrifugal force, rcf) change from 2200 g to . a range of 1800 - 2200 g. - Recommended tube spin time change from 15 minutes to a range of 10 15 . minutes.
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    K Number
    K102774
    Device Name
    VACUETTE QUICKSHIELD WITH SNAPPY TUDE HOLDER
    Manufacturer
    GREINER BIO-ONE NORTH AMERICA, INC.
    Date Cleared
    2010-10-15

    (21 days)

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

    GREINER BIO-ONE NORTH AMERICA, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Intended Use: The VACUETTE® QUICKSHIELD with SNAPPY Tube Holder is intended to be used only with VACUETTE® VISIO PLUS Blood Collection Needle with View Window and VACUETTE® Blood Collection Tubes as a system in routine venipuncture procedures. These devices are to be used by properly trained healthcare professionals only in accordance with these instructions.
    Device Description
    The VACUETTE® QUICKSHIELD with SNAPPY Tube Holder is a non-sterile single-use plastic tube holder. It 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. VACUETTE® QUICKSHIELD with SNAPPY Tube Holder helps secure VACUETTE® tubes in place during collection.
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    K Number
    K081929
    Device Name
    VACUETTE BLOOD COLLECTION TUBE WITH CLOT ACTIVATOR AND GEL SEPARATOR
    Manufacturer
    GREINER BIO-ONE NORTH AMERICA, INC.
    Date Cleared
    2008-12-16

    (162 days)

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

    GREINER BIO-ONE NORTH AMERICA, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    VACUETTE® Blood Collection Tubes with Clot Activator, Gel Separator, and Standard Stopper (16 x 100 mm, 8 mL) are used to collect, transport and process blood for testing serum in the clinical laboratory. In addition, the tubes are suitable for therapeutic drug monitoring (TDM).
    Device Description
    Greiner VACUETTE® Blood Collection Tube with Clot Activator and Gel Separator and Standard Stopper (16 x 100 mm, 8 mL)
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    K Number
    K072320
    Device Name
    GREINER VACUETTE QUICKSHIELD COMPLETE
    Manufacturer
    GREINER BIO-ONE NORTH AMERICA, INC.
    Date Cleared
    2007-09-14

    (25 days)

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

    GREINER BIO-ONE NORTH AMERICA, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The QUICKSHIELD Complete is intended to be used only with VACUETTE® Blood Collection Tubes as a system in routine venipuncture procedures. This device is to be used by properly trained healthcare professionals only in accordance with these instructions. This device 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. VACUETTE® VISIO PLUS Blood Collection Needles are designed for use in the daily blood collection routine when delegated by a qualified practitioner. The flashback window is situated in the transparent part of the cannula hub, which assists the user to recognize successful vein penetration. They are for single-use only and should only be used by adequately trained healthcare personnel in accordance with these instructions.
    Device Description
    The QUICKSHIELD Complete is intended to be used only with VACUETTE® Blood Collection Tubes as a system in routine venipuncture procedures. This device is to be used by properly trained healthcare professionals only in accordance with these instructions. This device 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. VACUETTE® VISIO PLUS Blood Collection Needles are designed for use in the daily blood collection routine when delegated by a qualified practitioner. The flashback window is situated in the transparent part of the cannula hub, which assists the user to recognize successful vein penetration. They are for single-use only and should only be used by adequately trained healthcare personnel in accordance with these instructions.
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    K Number
    K063357
    Device Name
    MINICOLLECT CAPILLARY BLOOD COLLECTION TUBES
    Manufacturer
    GREINER BIO-ONE NORTH AMERICA, INC.
    Date Cleared
    2007-07-10

    (245 days)

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

    GREINER BIO-ONE NORTH AMERICA, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Greiner Bio-One MiniCollect® Capillary Blood Collection Tubes are designed for the collection, transportation and processing of capillary blood (collected via lancet stick) whenever a small amount of blood is preferred. Greiner Bio-One MiniCollect® Capillary Blood Collection Tubes with dipotassium EDTA (K2EDTA) are used to obtain whole blood for testing parameters in hematology.
    Device Description
    Greiner Bio-One MiniCollect® Capillary Blood Collection Tubes with K2EDTA are non-evacuated, non-sterile, low sample volume tubes made from virtually unbreakable, highly transparent polypropylene. The tube measures 11 x 40 mm and there is a predefined nominal fill volume of 0.5 mL for achieving correct additive concentrations.
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    K Number
    K061483
    Device Name
    VACUETTE VISIO PLUS BLOOD COLLECTION NEEDLES
    Manufacturer
    GREINER BIO-ONE NORTH AMERICA, INC.
    Date Cleared
    2006-08-14

    (76 days)

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

    GREINER BIO-ONE NORTH AMERICA, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    VACUETTE® VISIO PLUS Blood Collection Needles are designed for use in the daily blood collection routine when delegated by a qualified practitioner.
    Device Description
    VACUETTE® VISIO PLUS Blood Collection Needles are manufactured from stainless steel and are fitted with a safety valve at one end. The flashback window is situated in the transparent part of the cannula hub, which assists the user to recognize successful vein penetration. The perforated label not only serves to simplify identification, but also acts as a seal of integrity. VACUETTE® VISIO PLUS Blood collection needles are a sterile single-use product. They are for single-use only and should only be used by adequately trained healthcare personnel in accordance with these instructions. The VACUETTE® VISIO PLUS Blood Collection Needles will be available in four configurations to include two needle gauge sizes (21G and 22G) and two corresponding needle lengths (25 mm [1 inch] and 38 mm [ 1 ½ inches]): - Needle gauge = 21G; Front needle length = 25 mm [1 inch] . - Needle gauge = 22G; Front needle length = 25 mm [1 inch] . - Needle gauge = 21G; Front needle length = 38 mm [1 ½ inch] . - Needle gauge = 22G; Front needle length = 38 mm [1 ½ inch] . The needles are packaged as sterile and are labeled for single use only. There is no ability to clean and reuse these devices.
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