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510(k) Data Aggregation

    K Number
    K240455
    Device Name
    BD Vacutainer® Citrate Blood Collection Tubes
    Manufacturer
    Becton Dickinson and Company
    Date Cleared
    2024-10-31

    (259 days)

    Product Code
    GIM
    Regulation Number
    862.1675
    Why did this record match?
    Product Code :

    GIM

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The BD Vacutainer® Citrate Blood Collection Tube (0.109M buffered sodium citrate) is a sterile, single use tube used for the collection, containment, transport, and centrifugation of venous blood specimens to obtain plasma for in vitro diagnostic testing. It is used in settings where a venous blood sample is collected by a trained healthcare worker. The BD Vacutainer® Citrate Blood Collection Tube is used for clinical laboratory testing in coagulation.
    Device Description
    BD Vacutainer® Citrate Blood Collection Tubes (BD Citrate Tubes) are available in plastic configurations and contain a liquid additive. Tubes include a color-coded BD Hemogard™ Closure and are comprised of an inner and outer tube to maintain the draw volume and liquid additive. Refer to Table 1 for unique product configurations. Tube stoppers are lubricated with silicone to facilitate stopper insertion. The buffered sodium citrate solution provides an anticoagulated specimen when used in accordance with the instructions for use. The tubes are compatible with the BD Vacutainer® Blood Collection Needles, Blood Collection Sets, Transfer Devices. Holders and Adaptors.
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    K Number
    K230493
    Device Name
    BD MiniDraw Capillary Blood Collection System with BD MiniDraw H&H Capillary Blood Collection Tube
    Manufacturer
    Becton Dickinson and Company
    Date Cleared
    2023-11-27

    (277 days)

    Product Code
    GIM
    Regulation Number
    862.1675
    Why did this record match?
    Product Code :

    GIM

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The BD MiniDraw™ Capillary Blood Collection System with BD MiniDraw™ Hemoglobin & Hematocrit (H&H) Capillary Blood Collection Tube with K2EDTA is used to collect, anticoagulate, transport, and store capillary whole blood samples from individuals 18 years and older. The System is comprised of a capillary blood collection tube and a BD MiniDraw™ Finger Sleeve that are intended for use by a trained healthcare worker. BD MiniDraw™ Capillary Blood Collection System with BD MiniDraw™™ H&H Capillary Blood Collection Tube is intended for sample collection used in the measurement of Hemoglobin (HgB) & Hematocrit (HCT), when analyzed on Sysmex XN - Series™ systems. The BD MiniDraw™ Capillary Blood Collection System with BD MiniDraw™ H&H Capillary Blood Collection Tube is not intended for use with other parameters.
    Device Description
    The MiniDraw™ H&H System is designed to collect, anticoagulate, transport, and store capillary blood samples from adults 18 years and older for measurement of hemoglobin and hematocrit requiring whole blood and is clinically equivalent to capillary and venous comparator tubes for both analytes. The system is comprised of a capillary blood collection tube and a Finger Sleeve that is intended for use by trained healthcare workers in ancillary healthcare facilities (e.g., retail pharmacies, clinical and laboratory use environments. It is intended to be used with Sysmex XN - Series™ Analyzers. The MiniDraw™ H&H System is intended to collect a whole blood specimen from a finger and deliver an anticoagulated sample for measurement of hemoglobin and hematocrit. The BD MiniDraw™ H&H Capillary Blood Collection Tube (MiniDraw™ H&H Tube) contains K2EDTA for anticoagulation of whole blood samples. The tube has a unique barcode that links the tube with the patient. The MiniDraw™ H&H Tube is designed to be used in combination with the BD MiniDraw™M Finger Sleeve (available in four sizes), the BD Microtainer® Contact-Activated Lancet (clearance K223243) and three accessories; BD MiniDraw™ Finger Sizing Tool, BD MiniDraw™ Capillary Tube Adapter H&H, and BD MiniDraw™ Cap Removal Tool.
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    K Number
    K213670
    Device Name
    BD Vacutainer K2EDTA Blood Collection Tubes, BD Vacutainer K3EDTA Blood Collection Tubes
    Manufacturer
    Becton Dickinson and Company
    Date Cleared
    2023-08-25

    (641 days)

    Product Code
    GIM
    Regulation Number
    862.1675
    Why did this record match?
    Product Code :

    GIM

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    BD Vacutainer® EDTA Blood Collection Tubes are evacuated, sterile, single use, in vitro diagnostic medical devices. They are intended to be used by trained healthcare professionals for the collection, containment, preservation, and transport of human venous blood specimens used for in vitro diagnostic testing. BD Vacutainer® K2EDTA and K3EDTA Blood Collection Tubes are used for testing in hematology including white blood cells (WBC), red blood cells (RBC), red blood cell distribution width (RDW), hemoglobin (HgB), hematocrit (HCT), mean corpuscular volume (MCV), mean corpuscular (MCH), mean corpuscular hemoglobin concentration (MCHC), platelets, and 5-part white blood cell (WBC) differential counts (neutrophils, lymphocytes, monocytes, eosinophils, basophils).
    Device Description
    BD Vacutainer® K2EDTA Blood Collection Tubes and BD Vacutainer® K3EDTA Blood Collection Tubes are for collecting, transporting and centrifuging blood in a closed tube. The blood collection tube consists of closure assembly, a glass tube and EDTA additive. The standard closure assembly is a basic rubber stopper. The tube is also available with the Vacutainer® Hemogard™ Closure Assembly which consists of a rubber stopper and protective plastic shield to reduce user exposure to blood. All stopper/closures are color coded to reflect additive type; the closures included in this submission are either pink or lavender to indicate the presence of the EDTA additive.
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    K Number
    K162723
    Device Name
    TransFix/EDTA Vacuum Blood Collection Tubes
    Manufacturer
    Caltag Medsystems Ltd.
    Date Cleared
    2017-06-22

    (266 days)

    Product Code
    GIM
    Regulation Number
    862.1675
    Why did this record match?
    Product Code :

    GIM

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    TransFix/EDTA Vacuum Blood Collection Tubes (TVTs) are intended for collection and storage of human whole blood specimens for immunophenotyping of white blood cells by flow cytometry. Recovery of lymphocyte subset markers of the HIV panel can be accomplished over a 14-day period following collection. TVTs are in-vitro diagnostic medical devices.
    Device Description
    TransFix®/EDTA Vacuum Blood Collection Tubes (TVTs) are intended for collection and storage of human whole blood specimens for immunophenotyping of white blood cells (WBC, leukocytes) by flow cytometry up to 14-days following collection; the TVTs preserve the qualitative and quantitative leukocyte subset characteristics. Flow cytometry is used to identify subsets of leukocytes that can be distinguished on the basis of cell surface antigens using fluorescent antibodies. The TransFix®/EDTA Vacuum Blood Collection Tubes (TVTs) consist of purple-capped polyethylene terephthalate blood collection tubes containing the paraformaldehyde based preservative, TransFix, and K2EDTA at the correct volume to simultaneously stabilize and anticoagulate human whole blood at the time of collection. TVTs hold 3mL (final draw volume) with a tube dimension of 13 x 75mm. TVTs are sterilized by gamma radiation. Further, the vacuum contained within the TVT ensures that the TransFix/EDTA reagent is administered at the correct ratio of 1 part TransFix/EDTA to 5 parts whole blood.
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    K Number
    K080552
    Device Name
    CYTO-CHEX BCT
    Manufacturer
    Streck
    Date Cleared
    2008-07-31

    (154 days)

    Product Code
    GIM
    Regulation Number
    862.1675
    Why did this record match?
    Product Code :

    GIM

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Cyto-Chex® BCT™ is intended for collection and storage of blood specimens for immunophenotyping of WBC by flowcytometry. Recovery of lymphocyte subset cell markers of the HIV panel can be accomplished over a 14-day period following collection.
    Device Description
    Cyto-Chex BCT consists of a standard 13 x 75mm glass blood collection tube containing 75.8ul of sterile KJEDTA anti-coagulant and WBC preservative. It is manufactured with a vacuum to draw 5ml of blood by venipuncture.
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    K Number
    K012152
    Device Name
    DS30 HCY BLOOD COLLECTION TUBES
    Manufacturer
    DREW SCIENTIFIC LTD.
    Date Cleared
    2001-09-18

    (69 days)

    Product Code
    GIM
    Regulation Number
    862.1675
    Why did this record match?
    Product Code :

    GIM

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Plastic, evacuated blood collection tube containing EDTA (anti-coagulant) and 3deazaadenosine (enzyme inhibitor) for the collection and stabilization of 2.5 mL whole blood prior to removal of plasma for total homocysteine measurement by HPLC for the detection of hyperhomocysteinæmia. prescription use
    Device Description
    Plastic, evacuated blood collection tube containing EDTA (anti-coagulant) and 3deazaadenosine (enzyme inhibitor)
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    K Number
    K971449
    Device Name
    VACUTAINER BRAND PLUS TUBE WITH EDTA ANTICOAGULANT(MULTIPLE)
    Manufacturer
    BECTON DICKINSON VACUTAINER SYSTEMS
    Date Cleared
    1997-06-17

    (57 days)

    Product Code
    GIM
    Regulation Number
    862.1675
    Why did this record match?
    Product Code :

    GIM

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The VACUTAINER® Brand PLUS (plastic) Tube with EDTA is an evacuated blood collection tube which provide a means of collecting, transporting, separating and processing blood in a plastic tube. When the tube is used together with VACUTAINER® Brand Needles and Holders, it is a closed system for the collection of venous blood with the same indications as described herein. Blood collected in a tube containing EDTA Anticoagulant is primarily used for clinical laboratory testing-hematology study using whole blood but may be used for other studies including such studies as testing for lead and FEP analyses, requiring whole blood as determined by the laboratory.
    Device Description
    The VACUTAINER® Brand PLUS Tube with EDTA is an evacuated plastic tube for collecting, transmitting and processing blood in a closed plastic tube. The blood collection tube consists of closure assembly, a plastic tube and EDTA coating (dipotassium, K2). The plastic tube is manufactured from PET (Polyethylene terepthalate Plastic and enhances user safety and disposal because of the reduced risk of tube breakage and incineration as a method of disposal. The standard closure assembly is a basic rubber stopper. The tube is also available with VACUTAINER Systems Hemogard™ Closure assembly which is designed to reduce user exposure to blood. The EDTA anticoagulant tube coating is spray coated in a dipotassium (K2) form. The EDTA prevents specimen coagulation.
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    K Number
    K971221
    Device Name
    GREINER VACUETTE BLOOD COLLECTION TUBE
    Manufacturer
    GREINER AMERICA, INC.
    Date Cleared
    1997-05-02

    (30 days)

    Product Code
    GIM
    Regulation Number
    862.1675
    Why did this record match?
    Product Code :

    GIM

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Greiner Vacuette® blood collection tube with sodium citrate is an evacuated blood collection device containing sodium citrate anticoagulant additive and intended for use in evaluations of coagulation analyses.
    Device Description
    The Greiner Vacuette® blood collection tube with sodium citrate is an evacuated blood collection device containing sodium citrate anticoagulant additive. The tube material for the Greiner product is clear plastic.
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