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510(k) Data Aggregation
K Number
K221634Device Name
Oxymag - Transport and Emergency Ventilator
Manufacturer
Magnamed Tecnologia Medica S/A
Date Cleared
2023-05-24
(352 days)
Product Code
BTL
Regulation Number
868.5925Why did this record match?
Applicant Name (Manufacturer) :
Magnamed Tecnologia Medica S/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Oxymag is a controlled volume, pressure and time cycled emergency and transport ventilator. It is intended for use with infant, child, and adult patients with a tidal volume from 50 ml upwards who are in respiratory and/or cardiac arrest or respiratory distress and who require the ventilatory support.
It is intended for pre-hospital and hospital use including intra-hospital, inter-hospital and transport settings.
Device Description
Oxymag provides a mixture of ambient air and oxygen at concentrations adjusted by the operator using the accurate oxygen concentration system using the venturi principle. O2 concentration is obtained through a galvanic cell by passing gas through the sensor. In addition, it performs the control of flows and pressures in the respiratory circuit to provide the ventilation modalities appropriate to the patient's condition.
The associated accessories include:
- Power outlet 12V/3,34A
- AC cable
- Disposable respiratory circuit
- 02 extension
- Environment filters
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