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510(k) Data Aggregation
K Number
K990659Device Name
NASAL AIRE
Manufacturer
BREATHING TECHNOLOGIES CORP.
Date Cleared
1999-11-26
(270 days)
Product Code
BZD
Regulation Number
868.5905Why did this record match?
Applicant Name (Manufacturer) :
BREATHING TECHNOLOGIES CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Nasal-Aire is intended for use as an accessory to respiratory ventilators. Ventilation is indicated for patients who require mechanical assistance with breathing.
Nasal Aire is an accessory to positive pressure ventilation devices (e.g. CPAP, Bi-level). It may also be used in respiratory insufficiencies if the patient can tolerate the excess dead space.
The Nasal-Aire cannot exhaust exhaled air therefore this device must be used with a ventilator that contains an active exhalation valve or with an intentional leak port added into the breathing circuit
Device Description
Nasal-Aire is a nasal insert with attached tubing for connection with non-continuous ventilation devices. The simplicity of the Nasal-Aire design allows easy manipulation of the device. Soft, pliable silicone is used for the nasal insert portion of the device facilitates a comfortable fit of the device when in use.
The Nasal-Aire accessory and associated tubing is intended for use in delivering ventilation to patients. The device consists of a hollow silicone elastomer under nose strip with molded nasal insert sleeves made from silicone elastomer. The under nose strip is fitted bilaterally with 3/8" Tygon® tubing which serves as conduits for ventilation. The tubing is joined to form a single ventilation conduit by a silicone elastomer "Y" coupling. The system is completed by the "Y" coupling connected to an adapter for connection to the main ventilators supply line. When the device is worn by the patient the under nose strip is positioned across the patient's upper lip and the silicone nasal inserts are inserted in the patient's nares. The tubing drapes over the patient's ears in the manner of standard nasal cannulae used for administering oxygen with the "Y" coupling positioned in front of the patient.
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