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510(k) Data Aggregation
K Number
K223863Device Name
BONHAWA Respiratory Humidifier
Manufacturer
Date Cleared
2023-10-13
(294 days)
Product Code
Regulation Number
868.5450Why did this record match?
Applicant Name (Manufacturer) :
Telesair, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The BONHAWA Respiratory Humidifier is intended to provide high flow warmed and humidified respiratory gases for administration to spontaneously breathing patients 20 kg and up, child to adults in hospitals. It adds heat and moisture to the flow of gases. The flow may be from 2 to 70 L/min depending on the patient interface.
The BONHAWA Respiratory Humidifier provides high flow gases with simultaneous oxygen delivery to spontaneously breathing patients without bypassed upper airways in hospitals.
Device Description
The BONHAWA Respiratory Humidifier is a heated humidifier with integrated blower, heater plate and heated breathing circuit that delivers warm and humidified respiratory gas to a patient via nasal cannula. A blower inside the device blends the externally provided oxygen with entrained filtered air and controls the gas flow rate delivered to the patient per the professional user established setting. An internal oxygen sensor monitors and reports the delivered oxygen concentration. The patient interface, heated breathing circuit chamber and chamber adapter are single use.
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