SonarMed AirWave

GUDID 20851334007043

AirWave Sensor - Neonatal Small - for use with endotracheal tubes of 2.5 mm ID

SONARMED, INC

Endotracheal secretion monitoring system
Primary Device ID20851334007043
NIH Device Record Keycca32861-60c1-4296-be60-0a0f0cd56cb7
Commercial Distribution StatusIn Commercial Distribution
Brand NameSonarMed AirWave
Version Model NumberAW-S0004
Company DUNS198245628
Company NameSONARMED, INC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100851334007049 [Primary]
GS110851334007046 [Package]
Contains: 00851334007049
Package: box [5 Units]
In Commercial Distribution
GS120851334007043 [Package]
Contains: 00851334007049
Package: box [10 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OQUAirway Monitoring System

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-24

On-Brand Devices [SonarMed AirWave]

20851334007111AirWave Sensor - Pediatric Extra Large - for use with endotracheal tubes of 5.5 or 6.0 mm ID
20851334007104AirWave Sensor - Pediatric Large - for use with endotracheal tubes of 5.0 mm ID
20851334007098AirWave Sensor - Pediatric Medium - for use with endotracheal tubes of 4.5 mm ID
20851334007081AirWave Sensor - Pediatric Small - for use with endotracheal tubes of 4.0 mm ID
00851334007070AirWave Reusable Sensor Cable - for Use with All Sizes of the AirWave Sensor
20851334007067AirWave Sensor - Neonatal Large - for use with endotracheal tubes of 3.5 mm ID
20851334007050AirWave Sensor - Neonatal Medium - for use with endotracheal tubes of 3.0 mm ID
20851334007043AirWave Sensor - Neonatal Small - for use with endotracheal tubes of 2.5 mm ID
20851334007036AirWave Sensor - Adult Large - for use with endotracheal tubes of 8.5 or 9.0 mm ID
20851334007029AirWave Sensor - Adult Medium - for use with endotracheal tubes of 7.5 or 8.0 mm ID
20851334007012AirWave Sensor - Adult Small - for use with endotracheal tubes of 6.5 or 7.0 mm ID
00851334007001AirWave Monitor - Portable/handheld monitor packaged with power transformer and electrical cord,
00851334007292AirWave Reusable Sensor Cable - for Use with All Sizes of the AirWave Sensor
10851334007282Adult SonarMed Sensor - for use with endotracheal tubes of 8.5 or 9.0 mm ID
00851334007261Adult SonarMed Sensor - for use with endotracheal tubes of 7.5 or 8.0 mm ID
10851334007251Adult SonarMed Sensor - for use with endotracheal tubes of 6.5 or 7.0 mm ID
10851334007244Pediatric SonarMed Sensor - for use with endotracheal tubes of 5.5 or 6.0 mm ID
10851334007237Pediatric SonarMed Sensor - for use with endotracheal tubes of 5.0 mm ID
10851334007220Pediatric SonarMed Sensor - for use with endotracheal tubes of 4.5 mm ID
10851334007213Pediatric SonarMed Sensor - for use with endotracheal tubes of 4.0 mm ID
10851334007206Neonatal SonarMed Sensor - for use with endotracheal tubes of 3.5 mm ID
10851334007190Neonatal SonarMed Sensor - for use with endotracheal tubes of 3.0 mm ID
10851334007183Neonatal SonarMed Sensor - for use with endotracheal tubes of 2.5 mm ID

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.