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510(k) Data Aggregation

    K Number
    K003062
    Device Name
    BACTEC MGIT 960 SIR KITS
    Manufacturer
    BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
    Date Cleared
    2001-06-06

    (247 days)

    Product Code
    MJA
    Regulation Number
    866.1640
    Why did this record match?
    Applicant Name (Manufacturer) :

    BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K003553
    Device Name
    0.9% SODIUM CHLORIDE INJECTION, USP BD PRE-FILLED FLUSH SYRINGE
    Manufacturer
    BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
    Date Cleared
    2001-03-21

    (124 days)

    Product Code
    FOZ
    Regulation Number
    880.5200
    Why did this record match?
    Applicant Name (Manufacturer) :

    BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K003461
    Device Name
    BD VACUTAINER PASSIVE SHIELDING BLOOD COLLECTION NEEDLE
    Manufacturer
    BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
    Date Cleared
    2001-02-01

    (86 days)

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

    BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K002938
    Device Name
    B-D ULTRA-FINE III PEN NEEDLE; MODEL 31G X 3/16
    Manufacturer
    BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
    Date Cleared
    2000-11-29

    (69 days)

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

    BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K002456
    Device Name
    MICROTAINER BRAND SODIUM FLUORIDE/EDTA TUBE WITH MICROGARD CLOSURE, MODEL 365992
    Manufacturer
    BECTON DICKINSON VACUTAINER SYSTEMS
    Date Cleared
    2000-11-02

    (84 days)

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

    BECTON DICKINSON VACUTAINER SYSTEMS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K001364
    Device Name
    BD DIRECTIGEN FLU A+B
    Manufacturer
    BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
    Date Cleared
    2000-06-28

    (58 days)

    Product Code
    PSZ
    Regulation Number
    866.3328
    Why did this record match?
    Applicant Name (Manufacturer) :

    BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K000762
    Device Name
    MOXIFLOXACIN, 5 UG, BBL SENSI-DISC
    Manufacturer
    BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
    Date Cleared
    2000-04-25

    (48 days)

    Product Code
    JTN
    Regulation Number
    866.1620
    Why did this record match?
    Applicant Name (Manufacturer) :

    BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K000829
    Device Name
    GATIFLOXACIN, 5 UG, BBL SENSI-DISC
    Manufacturer
    BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
    Date Cleared
    2000-04-13

    (30 days)

    Product Code
    JTN
    Regulation Number
    866.1620
    Why did this record match?
    Applicant Name (Manufacturer) :

    BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K993186
    Device Name
    SYNERCID, 15 UG, BBL SENSI-DISC
    Manufacturer
    BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
    Date Cleared
    1999-11-03

    (42 days)

    Product Code
    JTN
    Regulation Number
    866.1620
    Why did this record match?
    Applicant Name (Manufacturer) :

    BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Use of Synercid, 15 µg, BBL™ Sensi-Disc™ for in vitro agar diffusion susceptibility testing is indicated when there is a need to determine the susceptibility of bacteria to Synercid. Synercid indication whown to be active in vito against most strains of microorganisms listed below, as described in the Rhone Poulenc-Rorer package insert for this antimicrobic. Active In Vitro Against: Aerobic Gram Positive Microorganisms Enterococcus facium (Vancomycin-resistant and multi-drug resistant strains only) Staphylococcus aureus (methiclilin-susceptible strains only) Straptococcus pyoganes
    Device Description
    Antimicrobial Susceptibility Test Discs are used for semi-quantitative in vitro susceptibility testing by standardized agar diffusion test procedures. Synercid BBL® Sensi-Disc™ are intended for use in determining the susceptibility to Synercid of a wide range of bacteria, as described under Indications For Use below. Zone sizes used for interpretation of tests, including control organism limits, were determined by the antimicrobic manufacturer, Rhone Poulenc-Rorer, and received FDA approval under NDA Nos. 50-747 and 50-748. Synercid Susceptibility Test Discs are prepared by impregnating high quality paper with accurately determined amounts of Synercid supplied by the manufacturer, Rhone Poulenc-Rorer. Each Synercid disc is clearly marked on both sides with the agent and content. Synercid discs are furnished in cartridges of 50 discs each. Synercid cartridges are packed as either a single cartridge in a single box, or in a package containing ten cartridges. Agar diffusion methods employing dried filter paper discs impregnated with specific concentrations of antimicrobial agents were developed in the 1940's. In order to eliminate or minimize variability in the testing, Bauer et al. developed a standardized procedure in which Mueller Hinton Agar was selected as the test medium. Various regulatory agencies and standards-writing organizations subsequently published standardized reference procedures based on the Bauer-Kirby method. Among the earliest and most widely accepted of these standardized procedures were those published by the U.S. Food and Drug Administration (FDA) and the World Health Organization (WHO). The procedure was adopted as a consensus standard by the National Committee for Clinical Laboratory Standards (NCCLS) and is periodically updated. The latest NCCLS documents are M2-A6 (1/97) and M100=S9 (1/99). Discs containing a wide variety of antimicrobial agents are applied to the surface of Mueller Hinton Agar plates for Haemophilus Test Medium Agar for Haemophilus influenzae or Mueller Hinton Agar with 5% Sheep Blood for Streptococcus pneumoniae] inoculated with pure cultures of clinical isolates. Following incubation, the plates are examined and the zones of inhibition surrounding the discs are measured and compared with established zone size ranges for individual antimicrobial agents in order to determine the agent(s) most suitable for use in antimicrobial therapy. The determination as to whether the organism in question is susceptible (S), intermediate (I), or resistant (R) to an antimicrobial agent is made by comparing zone sizes to those found in the respective organism tables of NCCLS Document M2-A6 ("Performance Standards for Antimicrobial Disk Susceptibility Tests - Sixth Edition, Approved Standard", 1/97) and of NCCLS Document M100-S9 ("Performance Standards for Antimicrobial Susceptibility Testing", Ninth Informational Supplement, 1/99).
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    K Number
    K992734
    Device Name
    BECTON DICKINSON SYRINGE
    Manufacturer
    BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
    Date Cleared
    1999-10-01

    (49 days)

    Product Code
    MEG
    Regulation Number
    880.5860
    Why did this record match?
    Applicant Name (Manufacturer) :

    BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Becton Dickinson SafetyGlide™ Syringes are used for a variety of injections and aspirations of fluid from vials, ampules and parts of the body below the surface of the skin. The insulin syringe has scale lines in insulin units and is typically used for insulin injections. The allergy syringes come in test and treatment versions. The allergy test syringe has an intra-dermal bevel for intradermal injections. The allergy treatment syringe has a regular bevel which is typically used for subcutaneous injections. The tuberculin syringe has a regular bevel which can be used for any of the 3 types of common injections (intradermal, intra-muscular or subcutaneous). The SafetyGlide™ Syringe contains a mechanism that covers the needle point after use. In the activated position the needle cover guards against accidental needle sticks during normal handling and disposal of the used needle/syringe combination.
    Device Description
    Single-use syringe with needle protection system. Syringes sizes: .3, .5, & 1 ml. Function: Syringes are used for aspiration/injection of fluids. The device contains a mechanism that covers the needle point after use. In the activated position the needle cover guards against accidental needle sticks during normal handling and disposal of the used need as syringe combination.
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