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510(k) Data Aggregation
K Number
K070710Device Name
ACCUTRANS DISPOSABLE PRESSURE MONITORING SYSTEM
Manufacturer
BIOSENSORS INTERNATIONAL-USA
Date Cleared
2007-04-19
(36 days)
Product Code
DRS
Regulation Number
870.2850Why did this record match?
Applicant Name (Manufacturer) :
BIOSENSORS INTERNATIONAL-USA
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Accutrans Disposable Pressure Transducer Kit provides the fluid pathway components that are intended to convert the hemodynamic waveform from the patient's catheter, through the disposable pressure transducer with integrated pressure sensor, into electrical signals which can be displayed using separate monitoring equipment. The whole kit is fully disposable and consists of pressure monitoring lines and the Accutrans Disposable Pressure Transducer.
Accutrans Disposable Pressure Transducer: The disposable pressure transducer is provided with or without an integral 3cc/hr or 30cc/hr flush devices. Kits with Succhi flush devices are designed exclusively for use with a infusion pump for neonatal and infant applications. The disposable pressure transducer, with the integrated pressure sensor, is intended for direct coupling to sterile catheters with fluid (saline) flows in contact with the patient bloodstream. Accutrans Disposable Pressure Transducer Kits are available for modular assembly of an IV pole-mount transducer organizer system, or for portable on-patient mounting.
AccuTrans Pressure Monitoring Kits and AccuTrans Disposable Transducer are indirectly in contact with the blood path and hence, are supplied sterile and is intended for single use only. Pole-mounts, backplates and transducer adapter cables are accessories that are to be used externally outside the human body, and hence supplied non-sterile but hygienically clean. Between surgical cases of patient, suitable cleaning instructions should be followed to minimize cross contamination between patient and health worker.
Device Description
Biosensors's Accutrans Disposable Pressure Transducer System consists of a pressure monitoring kit with pressure tubing connected to the single-use disposable transducer with an integrated pressure sensor. The transducer can come with or without an integral flush device. The complete configuration can be pole-mounted or patient mounted and is provided sterile and non-pyrogenic.
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K Number
K022004Device Name
CARDIAC OUTPUT KIT, MODEL CO-1 & INLINE SENSOR CABLE, MODEL ILS-1
Manufacturer
BIOSENSORS INTERNATIONAL-USA
Date Cleared
2003-03-12
(266 days)
Product Code
DQO
Regulation Number
870.1200Why did this record match?
Applicant Name (Manufacturer) :
BIOSENSORS INTERNATIONAL-USA
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Biosensors Inline Sensor Assembly forms a close loop injectate system for cardiac output measurement. Inline Temperature Sensor and kits (Inline Sensor Assembly) are used in Critical Care and Surgery settings in coniunction with Thermodilution Catheters supplied by various manufacturers, including Biosensors (K911710), for measuring cardiac output of hemodynamically compromised patients by Thermodilution Technique. In this procedure, a known quantity of "room temperature" saline is injected from the Inline Sensor Assembly, and then through an internal catheter lumen to a proximal port of the catheter and into the patient's heart (right atrium). The room temperature saline mixes with the patients' blood as it is pumped by the heart through the right ventricle and into the pulmonary artery.
Biosensors Inline Sensor Assembly is designed for closed injectate delivery system use. It connects to the CVP lumen of a Thermodilution catheter to perform room temperature injections and determine a temperature reading. The inline temperature sensor housing connects to a reusable thermistor cable assembly (the Inline Temperature Assembly) that leads to a Marquette 7000 series Cardiac Output Computer. An inline check valve prevents reflux of fluid and/or blood into the system after injections. The intended use of Biosensors Inline Sensor Assembly is identical to that of Becton Dickinson's SP4572 disposable in-line injectate set.
Device Description
Biosensors Cardiac Output Kit is a sterile kit of disposables which includes an in-line iniectate sensor housing along with a 10 ml syringe. 3-way stopcock, a dual one-way check valve adaptor housing and a coil of IV tubing with spike and a tubing clamp. The check valve prevents reflux of fluid and/or blood into the system following injection of saline into a Thermodilution Catheter (not a part of this application).
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