FDA.reportPublic FDA data

SonarMed AirWave

Primary DI
00851334007100
Brand
SonarMed AirWave
Company
SONARMED, INC
Model
AW-S0014
Device description
AirWave Sensor - Pediatric Large - for use with endotracheal tubes of 5.0 mm ID
Published
2017-06-02
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
OQUAirway Monitoring System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OQUAirway Monitoring SystemAnesthesiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10851334007107PackageGS15Not in Commercial Distribution
20851334007104PackageGS110Not in Commercial Distribution
00851334007100PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085133400710710851334007107
2085133400710420851334007104
00851334007100008513340071008513340071000851334007100

GMDN Terms#

Term, Definition table
TermDefinition
Endotracheal secretion monitoring systemAn assembly of mains electricity (AC-powered) devices designed to continuously detect the sound of endotracheal (ET) secretions moving through a ventilation circuit during suctioning of an artificially ventilated and/or spontaneously breathing patient to asses the effectiveness of suctioning. It typically consists of a disposable sensor (a microphone) connected to the ventilation circuit, and a monitor that displays the signals acoustically and/or visually. It is typically used on cardiac, pulmonary, neurological, postoperative, and trauma patients in a healthcare facility or in the home.

Regulatory Flags#

DUNS number
198245628
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00851334007018SonarMed AirWaveAW-S00012016-09-24
00851334007025SonarMed AirWaveAW-S00022016-09-24
00851334007032SonarMed AirWaveAW-S00032016-09-24
00851334007049SonarMed AirWaveAW-S00042016-09-24
00851334007056SonarMed AirWaveAW-S00052016-09-24
00851334007063SonarMed AirWaveAW-S00062016-09-24
00851334007087SonarMed AirWaveAW-S00122017-06-02
00851334007094SonarMed AirWaveAW-S00132017-06-02
00851334007117SonarMed AirWaveAW-S00152017-06-02
00851334007186SonarMed AirWaveAW-S0252021-03-08
00851334007193SonarMed AirWaveAW-S0302021-03-08
00851334007209SonarMed AirWaveAW-S0352021-03-08
00851334007216SonarMed AirWaveAW-S0402021-03-08
00851334007223SonarMed AirWaveAW-S0452021-03-08
00851334007230SonarMed AirWaveAW-S0502021-03-08
00851334007247SonarMed AirWaveAW-S0552021-03-08
00851334007254SonarMed AirWaveAW-S0652021-03-08
00851334007285SonarMed AirWaveAW-S0852021-03-08
00851334007261SonarMed AirWaveAW-S0752021-03-08
00851334007292SonarMed AirWaveAW-SC052021-03-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00851334007186SonarMed AirWaveSONARMED, INCOQU2021-03-08
00851334007193SonarMed AirWaveSONARMED, INCOQU2021-03-08
00851334007209SonarMed AirWaveSONARMED, INCOQU2021-03-08
00851334007216SonarMed AirWaveSONARMED, INCOQU2021-03-08
00851334007223SonarMed AirWaveSONARMED, INCOQU2021-03-08
00851334007230SonarMed AirWaveSONARMED, INCOQU2021-03-08
00851334007247SonarMed AirWaveSONARMED, INCOQU2021-03-08
00851334007254SonarMed AirWaveSONARMED, INCOQU2021-03-08
00851334007285SonarMed AirWaveSONARMED, INCOQU2021-03-08
10851334007183SonarMed AirWaveSONARMED, INCOQU2021-03-08
10851334007190SonarMed AirWaveSONARMED, INCOQU2021-03-08
10851334007206SonarMed AirWaveSONARMED, INCOQU2021-03-08
10851334007213SonarMed AirWaveSONARMED, INCOQU2021-03-08
10851334007220SonarMed AirWaveSONARMED, INCOQU2021-03-08
10851334007237SonarMed AirWaveSONARMED, INCOQU2021-03-08
10851334007244SonarMed AirWaveSONARMED, INCOQU2021-03-08
10851334007251SonarMed AirWaveSONARMED, INCOQU2021-03-08
00851334007261SonarMed AirWaveSONARMED, INCOQU2021-03-08
10851334007282SonarMed AirWaveSONARMED, INCOQU2021-03-08
00851334007292SonarMed AirWaveSONARMED, INCOQU2021-03-08
00851334007087SonarMed AirWaveSONARMED, INCOQU2017-06-02
00851334007094SonarMed AirWaveSONARMED, INCOQU2017-06-02
00851334007117SonarMed AirWaveSONARMED, INCOQU2017-06-02
20851334007081SonarMed AirWaveSONARMED, INCOQU2017-06-02
20851334007098SonarMed AirWaveSONARMED, INCOQU2017-06-02
20851334007104SonarMed AirWaveSONARMED, INCOQU2017-06-02
20851334007111SonarMed AirWaveSONARMED, INCOQU2017-06-02
00815277020596CuraplexBOUND TREE MEDICAL, LLCOQU2016-12-14
00815277027700CuraplexBOUND TREE MEDICAL, LLCOQU2016-12-14
00815277028059CuraplexBOUND TREE MEDICAL, LLCOQU2016-12-14