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510(k) Data Aggregation
K Number
K173147Device Name
SuperNO2VA Et Device
Manufacturer
Date Cleared
2018-06-20
(264 days)
Regulation Number
868.1400Why did this record match?
Applicant Name (Manufacturer) :
Revolutionary Medical Devices, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The SuperNO2VA Et™ Device is a nasal mask that creates a seal when positioned over a patient's nose to direct anesthesia gas, air, and / or oxygen to the upper airway during the continuum of anesthesia care.
It has a means for sampling expired gases from the patient's exhaled breath from the oral / nasal areas.
The SuperNO2VA Et™ Device is intended for short-term (<24 hours) use on adult patients (>30 kg.). It is a single patient use, disposable.
The SuperNO2VA Et™ Device is contraindicated for use in long-term ventilation conditions and treatment of sleep apnea.
To be used under clinical supervision with adequate alarms and safety systems for monitoring and treatment of ventilatory failure.
Device Description
The SuperNO2VA Et™ Device is a nasal mask with a sampling port for the nasal portion and a sampling "hood" for over the mouth.
The subject device is similar to an anesthesia or oxygen mask with gas sampling port. Instead of covering the full face the SuperNO2VA Et™ Device design is to allow the clinician to have access to the oral cavity during a procedure but still be able to provide air, oxygen or anesthesia gases to the patient while also sampling expired gases from the nasal or oral areas.
The design incorporates the standard 15 mm male circuit connector, luer fitting for the gas sampling line and a slip-fit port for pressure monitoring or oxygen if the mask is used with a manual resuscitator or hyperinflation bag.
The mask is not considered a long-term use device as it would only be used from pre- to postoperative care. This would be similar to the standard anesthesia mask.
It is not for use in long-term ventilation conditions or the treatment of sleep apnea.
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K Number
K163277Device Name
SuperNO2VA Device
Manufacturer
Date Cleared
2017-10-13
(326 days)
Product Code
Regulation Number
868.5550Why did this record match?
Applicant Name (Manufacturer) :
Revolutionary Medical Devices, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The SuperNOsY A™ Device is a mask that creates a seal when positioned over a patient's nose and mouth, or nose only, to direct anesthesia gas, air, and / or oxygen to the continum of anesthesia care. To be used under clinical supervision with adequate alarms and safety systems for monitoring and treatment of ventilatory failure.
The SuperNOsVA™ Device is intended for short-term (<24 hours) use on adult patients (>30 kg.) It is a single patient use, disposable.
The SuperNOsY A™ Device is contraindicated for use in long-term ventilation and treatment of sleep apnea.
Device Description
The SuperNO>VA™ is a 2-piece construction with a nasal and an oral portion. When assembled together the oral portion is connected to the nasal portion (chamber) contains 2 one way (duck bill) valves which are normally closed until the oral chamber is connected. Then gas passes through each portion to the patient. If one desires to remove the oral chamber during a procedure which requires oral access, then gas can still be provided via the nasal portion. Depending upon the equipment and the clinician's desire one can provide non-invasive positive pressure ventilation as well.
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