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510(k) Data Aggregation
K Number
K103523Device Name
185A+ TRANSPORT INCUBATOR WITH MASIMO PULSEOX, 185A+ TRANSPORT INCUBATOR WITH NELLCOR PULSEOX
Manufacturer
INTERNATIONAL BIOMEDICAL, LTD.
Date Cleared
2011-05-11
(161 days)
Product Code
FPL
Regulation Number
880.5410Why did this record match?
Applicant Name (Manufacturer) :
INTERNATIONAL BIOMEDICAL, LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The transport incubator is a neonatal transport incubator. The incubator circulates warmed air at an operator selected, controlled temperature into a transparent chamber containing an infant. The structural integrity and weight of the incubator makes it suitable for ground and air transport. Auxiliary equipment for airway management and vital signs monitoring are not standard equipment. The system is to be operated by trained medical technical personnel.
Device Description
The 185A+ Transport Incubator with PulseOx (hereafter referred to as the transport incubator) maintains a thermally regulated environment to prevent infant heat loss when transporting neonatal infants to hospitals prepared for neonatal infant care. The transport incubator maintains a thermally regulated environment with either externally supplied power or internal power supplied by a rechargeable battery. The transport incubator is also designed to offer integrated pulse oximetry and oxygen monitoring capability on the display panel. The transport incubator is also designed to carry equipment designed for life support and monitoring of the neonatal infant's status. The equipment includes but is not restricted to: hand and mechanical operated ventilator's; ventilator monitors; infusion pumps; patient monitors indicating blood pressure, respiration. electrocardiogram, oxygen saturation, pulse, etc.; suction pumps; oxygen analyzers; air and oxygen cylinders; air compressors; etc.
The integrated pulse oximeter feature is designed to use either Nellcor or Masimo technology. The Nellcor PulseOx model utilizes a daughter board and patient cabling provided by Nellcor. The Masimo PulseOx model utilizes a daughter board and patient cabling provided by Masimo.
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K Number
K103525Device Name
A750I TRANSPORT INCUBATOR WITH MASIMO PLUSEOX, A750I TRANSPORT INCUBATOR WITH NELLOR PULSEOX
Manufacturer
INTERNATIONAL BIOMEDICAL, LTD.
Date Cleared
2011-05-11
(161 days)
Product Code
FPL
Regulation Number
880.5410Why did this record match?
Applicant Name (Manufacturer) :
INTERNATIONAL BIOMEDICAL, LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The transport incubator is a neonatal transport incubator. The incubator circulates warmed air at an operator selected, controlled temperature into a transparent chamber containing an infant. The structural integrity and weight of the incubator makes it suitable for ground and air transport. Auxiliary equipment for airway management and vital signs monitoring are not standard equipment. The system is to be operated by trained medical technical personnel.
Device Description
The A750i Transport Incubator with PulseOx (hereafter referred to as the transport incubator) maintains a thermally regulated environment to prevent infant heat loss when transporting neonatal infants to hospitals prepared for neonatal infant care. The transport incubator maintains a thermally regulated environment with either externally supplied power or internal power supplied by a rechargeable battery. The transport incubator is also designed to offer integrated pulse oximetry and oxygen monitoring capability on the display panel. The transport incubator is also designed to carry equipment designed for life support and monitoring of the neonatal infant's status. The equipment includes but is not restricted to: hand and mechanical operated ventilator's; ventilator monitors; infusion pumps; patient monitors indicating blood pressure, respiration, electrocardiogram, oxygen saturation, pulse, etc.; suction pumps; oxygen analyzers; air and oxygen cylinders; air compressors; etc. The integrated pulse oximeter feature is designed to use either Nellcor or Masimo technology. The Nellcor PulseOx model utilizes a daughter board and patient cabling provided by Nellcor. The Masimo PulseOx model utilizes a daughter board and patient cabling provided by Masimo.
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K Number
K103524Device Name
VOYAGER TRANSPORT INCUBATOR WITH MASIMO PULSEOX, VOYAGER TRANSPORT INCUBATOR WITH NELLCOR PULSEOX
Manufacturer
INTERNATIONAL BIOMEDICAL, LTD.
Date Cleared
2011-04-15
(135 days)
Product Code
FPL
Regulation Number
880.5410Why did this record match?
Applicant Name (Manufacturer) :
INTERNATIONAL BIOMEDICAL, LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The transport incubator is intended for use by personnel trained in neonatal care to facilitate the movements of neonates by air or ambulance. The transport incubator circulates warmed air at an operator selected and controlled temperature when transporting neonatal infants to hospitals prepared for neonatal infant care. The transport incubator is also intended to carry equipment designed for airway management and monitoring of the neonatal infant's status.
Device Description
The Voyager Infant Transport Incubator with PulseOx (hereafter referred to as the transport incubator) maintains a thermally regulated environment to prevent infant heat loss when transporting neonatal infants to hospitals prepared for neonatal infant care. The transport incubator maintains a thermally regulated environment with either externally supplied power or internal power supplied by a rechargeable battery. The transport incubator is also designed to offer integrated pulse oximetry and oxygen monitoring capability on the display panel. The transport incubator is also designed to carry equipment designed for life support and monitoring of the neonatal infant's status. The equipment includes but is not restricted to: hand and mechanical operated ventilator's; ventilator monitors: infusion pumps; patient monitors indicating blood pressure, respiration, electrocardiogram, oxygen saturation, pulse, etc .; suction pumps; oxygen analyzers; air and oxygen cylinders; air compressors; etc. The integrated pulse oximeter feature is designed to use either Nellcor or Masimo technology. The Nellcor PulseOx model utilizes a daughter board and patient cabling provided by Nellcor. The Masimo PulseOx model utilizes a daughter board and patient cabling provided by Masimo.
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K Number
K103527Device Name
AVIATOR TRANSPORT INCUBATOR WITH MASIMO PULSEOX, AVIATOR TRANSPORT INCUBATOR WITH NELLCOR PULSEOX
Manufacturer
INTERNATIONAL BIOMEDICAL, LTD.
Date Cleared
2011-04-15
(135 days)
Product Code
FPL
Regulation Number
880.5410Why did this record match?
Applicant Name (Manufacturer) :
INTERNATIONAL BIOMEDICAL, LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The transport incubator is intended for use by personnel trained in neonatal care to facilitate the movements of neonates by air or ambulance.
Device Description
The Aviator Transport Incubator with PulseOx (hereafter referred to as the transport incubator) maintains a thermally regulated environment to ar uc heat loss when transporting neonatal infants to hospitals prepared for neonatal infant care. The transport incubator maintains a thermally regulated environment with either externally supplied power or internal power supplied by a rechargeable battery. The transport incubator is also designed to offer interes of a rece oximetry and oxygen monitoring capability on the display panel. The transport incubator is also designed to carry equipment designed for life support and monitoring of the neonatal infant's status. The equipment includes but is not restricted to: hand and mechanical operated ventilator's; ventilator monitors; infusion pumps; patient monitors indicating blood pressure, respiration. electrocardiogram, oxygen saturation, pulse, etc.; suction pumps; axygen analyzers; air and oxygen cylinders; air compressors; etc. The integrate pulse oximeter feature is designed to use either Nellcor or Masimo technology. The Nellcor PulseOx model utilizes a daughter board or of Wiest cabling provided by Nellcor. The Masimo PulseOx model utilizes a daughter board and patient cabling provided by Masimo.
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K Number
K093260Device Name
AERONOX NITRIC OXIDE TITRATION & MONITORING SYSTEM
Manufacturer
INTERNATIONAL BIOMEDICAL, LTD.
Date Cleared
2009-12-16
(58 days)
Product Code
MRN
Regulation Number
868.5165Why did this record match?
Applicant Name (Manufacturer) :
INTERNATIONAL BIOMEDICAL, LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The AeroNOx is intended to provide a constant controlled concentration of nitric oxide in breathing gas by delivering a constant controlled flow of nitric oxide into the inspiratory limb of a mechanical ventilator that operates using a continuous constant flow of fresh gas into the inspiratory limb of the ventilator. The AeroNOx is also intended to be used with a flow inflating manual ventilator (an AeroNOx accessory), by introducing controlled flows of nitric oxide into the fresh gas flow to the manual ventilator. It is also intended to monitor nitric oxide, nitrogen dioxide, and oxygen concentrations in the breathing gas. The AeroNOx is intended to be used within a hospital or during air or ground transport outside the hospital.
Device Description
The AeroNOx nitric oxide delivery system is specifically designed for the transmission . and control of gaseous nitric oxide (NO) in parts per million (ppm) concentrations. It is divided into two main components: the titration delivery system and the NO/NO2/O2 . analyzer. These two components are mounted into a single enclosure. The construction materials are compatible with NO and will not contaminate the gas stream. A stainless steel, two stage regulator with CGA 626 gas fittings is coupled to a calibrated, high accuracy NO mass flow meter and precision metering valve. The NO is titrated continuously via tubing nearest to the ventilator outlet circuit where it is diluted by the ventilator gas flow. Initial NO flow required to approximate a desired NO concentration is estimated by calculation and verified by the monitoring component of the system. We have also included a look-up table for specific ventilator settings, AeroNOx NO flow setting and expected NO2 production based on 100% Oxygen source, in the operating manual. The AeroNOx analyzer continuously draws a sample from the ventilator circuit on the distal point of the inspiratory circuit nearest the patient wye connection. The sensors then measure NO and NO2 concentration in parts per million and Oxygen in %. The sensors operate by electrochemical means. NO, O2 and NO2 molecules diffuse across a membrane and react in the electrolyte solution augmenting an electrical current between the anode and cathode. The augmented current is proportional to the NO, O2 and NO2 concentration. The AeroNOx analyzer has been designed so that the user can set alarm limits to ensure that deviations in NO and NO2 can be monitored. These alarms are visual and audible. An oxygen analyzer is also incorporated into the system to act as a secondary monitor to display the fractional inspired oxygen concentration.
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K Number
K081399Device Name
AVIATOR TRANSPORT INCUBATOR
Manufacturer
INTERNATIONAL BIOMEDICAL, LTD.
Date Cleared
2008-06-06
(18 days)
Product Code
FPL
Regulation Number
880.5410Why did this record match?
Applicant Name (Manufacturer) :
INTERNATIONAL BIOMEDICAL, LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The transport incubator is intended to be used to transport neonatal infants including transport in ambulances or aircraft and to be used by personnel trained in neonatal care.
Device Description
Not Found
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