FDA.reportPublic FDA data

SonarMed AirWave

Primary DI
20851334007104
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
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
OQUAirway Monitoring System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OQUAirway Monitoring SystemAnesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K143042000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K143042000SonarMed AirWave, Airway Monitoring SystemSonarmed, Inc.2016-01-22OQU

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10851334007107PackageGS15In Commercial Distribution
20851334007104PackageGS110In 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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
198245628
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
00851334007100SonarMed AirWaveAW-S00142017-06-02
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

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
00851334007100SonarMed AirWaveSONARMED, INCOQU2017-06-02
00851334007117SonarMed AirWaveSONARMED, INCOQU2017-06-02
20851334007081SonarMed AirWaveSONARMED, INCOQU2017-06-02
20851334007098SonarMed 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