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The BD Preset™ Syringe & BD A-Line™ Syringe are sterile, single use medical devices specifically intended to be used for the collection of whole blood specimens for the purpose of in vitro diagnostic testing which may include: pH, blood gases, electrolytes (including ionized calcium), metabolytes, co-oximetry. The device is intended to be used by trained healthcare professionals.

The BD Preset™ Syringe & BD A-Line™ Syringe is a sterile, single use device designed to collect whole blood specimens for diagnostic testing. The BD A-Line™ Syringe is specifically designed for aspiration of blood samples from arterial lines. The BD Preset™ Syringe is offered with and without a pre-attached Eclipse™ needle and is specifically designed to preset a desired volume but permits aspiration when necessary. It also includes a venting system that expels residual air through the self-venting membrane (as blood fills the syringe), which ensures rapid filling. The syringe is individually packaged, and Gamma sterilized with an SAL of 10-6.

The BD SoloShot™ Mini Syringe/ BD Auto Disable Syringe is intended for aspiration and injection of fluids.

The BD SoloShot™ Mini Syringe/ BD Auto Disable Syringe device is a sterile two-piece piston syringe designed to deliver a single fixed dose. It features a permanently attached hypodermic needle and auto-disable feature that prevents reuse of the syringe by locking the plunger rod in place after injection. The SoloShot™ Mini Syringe consists of a syringe barrel, a one-piece plunger rod (without rubber stopper), a clip affixed to the plunger rod and a integral needle is protected with a shield cover. The clip activates the auto-disabled feature, preventing re-use of the syringe is individually blister packaged and ETO sterilized to SAL of 10-6 .

The BD Intelliport™ system is an automated record keeping system that incorporates patient safety features that are aligned with hospital patient records and protocols. The system is comprised of an injection port and software that enables the identification, measurement, alerting and documentation of the administration of medications to patients. The BD Intelliport™ system allows the clinician to record anesthesia-related, medication administration events in the pre-op, intra-op, and PACU. The system is indicated for use by healthcare professionals in a hospital or medical center setting with patients who are receiving manually administered bolus intravenous injections as part of their care to facilitate documentation of the medications. The BD Intelliport™ system is intended for patients whose body weights are >20kg. The BD Intelliport™ system is not intended for use with blood, blood products, biologics, or chemotherapeutics. The BD Intelliport™ system is not intended for use with refrigerated medications (excluding cefazolin)

Like the cited predicate device, the BD Intelliport Medication Management System, Version 1.2 is a system of hardware and software components that measures the delivered volume of intravenous (IV) bolus medications associated with anesthesiarelated, medication administration events in the pre-op, intra-op, and PACU, and provides automated documentation of medication identity, concentration, dose, delivered volume, and delivery timestamp to the hospital electronic medical record (EMR) system. There are two modes: EMR mode and Standalone mode. Standalone mode allows for printing dose history reports, but is not connected to an EMR The device is organized by three subsystems, each of which includes several physical/software components: - . Injection Site subsystem - . Tablet subsystem - . Gateway subsystem The Injection Site subsystem is composed of two physical components (the Base and the ultrasonic Sensor) and the software residing inside the Base. The Tablet subsystem is composed of one physical component (the Tablet) and the software residing inside the Tablet. The Gateway subsystem consists of the Gateway software and the hospital server hardware on which the Gateway software resides. The device also includes an accessory for charging up to five Bases simultaneously. During treatment, the clinician connects an intelligent injection port (the Injection Site) to a patient's fluid-delivery line and performs standard drug-delivery activities. The clinician injects the druq using BD Luer Lok, 1-60ml size syringes only, and then flushes with a separate normal, saline syringe. Flushing after each administration ensures all medication is administered to patient since there is a 0.334 ml dead space. The device can be used with both encoded and non-coded syringes. If an encoded syringe is used, the device reads the two-dimensional barcode adhered to the syringe. The barcode contains information about the content in the syringe including the drug name and concentration. If a noncoded syringe is used, then the end user is prompted by the Tablet software to pick the drug name and concentration from the Encoded Drug List (EDL). When an encoded syringe is first connected to the device, the name of the drug is read back to the clinician and an allergy alert will trigger on the Injection Site base if the patient is allergic to the medication based on the patient's allergies record in their EHR (electronic health record). As the drug is injected, the device measures the volume of the injected drug via an ultrasonic sensor and records the time the drug was administered. Drug delivery information is stored and inserted into the patient's EHR by way of the Tablet and Gateway software in the EMR mode and available for printing in the Standalone mode.

The BD Phoenix™ Automated Microbiology System is intended for in vitro quantitative determination of antimicrobial susceptibility by minimal inhibitory concentration (MIC) of most Gram-negative aerobic and facultative anaerobic bacteria isolates from pure culture for Enterobacteriaceae and Non-Enteriaceae and most Gram-positive bacteria isolates from pure culture belonging to the genera Staphylococcus, Enterococcus and Streptococcus. Ceftolozane/tazobactam has been shown to be active in vitro against most strains of microorganisms listed below, as described in the FDA-approved package insert for this antimicrobial agent. Active In Vitro and in Clinical Infections Against: Gram-negative bacteria Enterobacter cloacae Escherichia coli Klebsiella oxytoca Klebsiella pneumoniae Proteus mirabilis Pseudomonas aeruginosa Active In Vitro but clinical significance is unknown: Gram-negative bacteria Citrobacter koseri Morganella morganii Proteus vulgaris Providencia stuartii Serratia liquefaciens Serratia marcescens

The BD Phoenix™ Automated Microbiology System (Phoenix System) is an automated system for the rapid identification (ID) and antimicrobial susceptibility testing (AST) of clinically relevant bacterial isolates. The system includes the following components: - . BD Phoenix instrument and software. - . BD Phoenix panels containing biochemicals for organism ID testing and antimicrobial agents for AST determinations. - . BD Phoenix ID Broth used for performing ID tests and preparing AST Broth inoculum. - . BD Phoenix AST Broth used for performing AST tests only. - . BD Phoenix AST Indicator solution added to the AST Broth to aid in bacterial growth determination. The Phoenix panel is a sealed and self-inoculating molded polystyrene tray with 136 micro-wells containing dried reagents. Organisms for susceptibility testing must be a pure culture and preliminarily identified as a Gram-negative or Gram-positive isolate. Phoenix panels are inoculated with a specified organism density and placed into the instrument. Inoculum for use with the Phoenix system may be prepared either manually or may be automated using the BD PhoenixTM AP System. The Phoenix AST method is a broth based microdilution test. The Phoenix System utilizes a redox indicator for the detection of organism growth in the presence of an antimicrobial agent. Measurements of changes to the indicator as well as bacterial turbidity are used in the determination of bacterial growth. Each AST panel configuration contains several antimicrobial agents with a wide range of two-fold doubling dilution concentrations. The instrument houses the panels where they are continuously incubated at a nominal temperature of 35 ℃ ± 1 °C. The instrument takes readings of the panels every 20 minutes. The readings are interpreted to give an identification of the isolate, minimum inhibitory concentration (MIC) values and category interpretations, S, I, R or N (susceptible, intermediate, resistant or not susceptible).

The BD MAX CT/GC/TV assay, as performed using the BD MAX System incorporates automated DNA extraction and real-time polymerase chain reaction (PCR) for the direct, qualitative detection of DNA from Chlamydia (CT), Neisseria gonorrhoeae (GC) and/or Trichomonas vaginalis (TV). The assay may be used for detection of CT and/or GC DNA in male urine specimens, and the detection of CT, GC and/or TV DNA in female urine specimens, cliniciancollected female endocervical swab speciment-collected vaginal swab specimens (in a clinical setting). The assay is indicated for use to aid in the diagnosis of chlamydial urogenital disease, gonococcal urogenital disease and/or trichomoniasis in asymptomatic and symptomatic individuals.

The BD MAX System and the BD MAX CT/GC/TV are comprised of an instrument with associated hardware and accessories, disposable microfluidic cartridges, master mixes, unitized reagent strips, and extraction reagents. The instrument automates sample preparation including target lysis, DNA extraction and concentration, reagent rehydration, and target nucleic acid amplification and detection using real-time PCR. The assay includes a Sample Processing Control (SPC) that is present in the Extraction Tube. The SPC monitors DNA extraction steps, thermal cycling steps, reagent integrity and the presence of inhibitory substances. The BD MAX System software automatically interprets test results. A test result may be called as POS, NEG or UNR for each of the assay's targets, based on the amplification status of the target and of the Sample Processing Control. IND (Indeterminate) or INC (Incomplete) results are due to BD MAX System failure.