Prefilled Compact Disposable Bubble Humidifier

Prefilled Compact Disposable Bubble Humidifier

INTRODUCTION:

 Title: COMPACT DISPOSABLE BUBBLE HUMIDIFIER

Is a prefilled , disposable, sterile device that is intended to humidify breathing gas prior to delivery to patient. CDH-350 is provided with a 6 PSI safety valve, and can operate within the flow rates of 6 to  15 LPM. The device is used with various breathing gas sources (i.e: oxygen concentrators, gas cylinders and wall outlets) and provides connection  for delivery of humidified breathing gas via face masks and cannulas.

The device is made from blow molding mold with only one component for the bottle. The bottle is marked with quantity water level.

PRODUCT INTENDED USE:

IS a device that intended to add moisture to breathing gases for admission to a patient.

The bubble humidifier is indicated for use with oxygen concentrators or gas sources in homecare, hospital, extended care facilities and hospice environments. The bubble humidifier is a sterile device indicated for single-patient usage. The device is indicated for patients who require humidification of high flow supplemental breathing gases.

Technology:

CDH-350 is substantially equivalent to the predicate device with regard to design, materials, performance and intended use. The difference is in the operating gas flow rates of 6 to 15 LPM that still produces a humidifier output of at least 10mgH2O/L in accordance with ASTM F1690 (Clause 49.1).

 

 

 

 

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