Search Results
Found 33 results
510(k) Data Aggregation
K Number
K003062Device 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
866.1640Why 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
Ask a Question
K Number
K003553Device 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
880.5200Why 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
Ask a Question
K Number
K003461Device 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
880.5570Why 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
Ask a Question
K Number
K002938Device 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
880.5570Why 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
Ask a Question
K Number
K001364Device 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
866.3328Why 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
Ask a Question
K Number
K000762Device 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
866.1620Why 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
Ask a Question
K Number
K000829Device 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
866.1620Why 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
Ask a Question
K Number
K993186Device 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
866.1620Why 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).
Ask a Question
K Number
K992734Device Name
BECTON DICKINSON SYRINGE
Manufacturer
BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
Date Cleared
1999-10-01
(49 days)
Product Code
MEG
Regulation Number
880.5860Why 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.
Ask a Question
K Number
K991551Device Name
VACUTAINER BRAND SODIUM CITRATE PEDIATRIC TUBE
Manufacturer
BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
Date Cleared
1999-09-23
(143 days)
Product Code
JKA
Regulation Number
862.1675Why did this record match?
Applicant Name (Manufacturer) :
BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The VACUTAINER® Brand Sodium Citrate Pediatric Tube is an evacuated blood collection tube which provides a means of collecting, transporting and processing blood in a closed tube. Blood collected in a tube containing Sodium Citrate anticoagulant is used primarily for clinical laboratory coagulation assays.
Device Description
The VACUTAINER® Brand Sodium Citrate Pediatric Tubes are sterile, glass, evacuated blood collection tubes. The tube contains Sodium Citrate as an anticoagulant intended to prevent whole blood from clotting prior to analysis. The specimen is centrifuged and the plasma portion is analyzed for the coagulation parameters to detect clotting time disorders and/or monitor patients undergoing anticoagulation therapy.
Ask a Question
Page 1 of 4