| Primary Device ID | 20851334007050 |
| NIH Device Record Key | 84159fe8-dee4-4461-8ca4-2589957ac0bb |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SonarMed AirWave |
| Version Model Number | AW-S0005 |
| Company DUNS | 198245628 |
| Company Name | SONARMED, INC |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00851334007056 [Primary] |
| GS1 | 10851334007053 [Package] Contains: 00851334007056 Package: box [5 Units] In Commercial Distribution |
| GS1 | 20851334007050 [Package] Contains: 00851334007056 Package: box [10 Units] In Commercial Distribution |
| OQU | Airway Monitoring System |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-09-24 |
| 20851334007111 | AirWave Sensor - Pediatric Extra Large - for use with endotracheal tubes of 5.5 or 6.0 mm ID |
| 20851334007104 | AirWave Sensor - Pediatric Large - for use with endotracheal tubes of 5.0 mm ID |
| 20851334007098 | AirWave Sensor - Pediatric Medium - for use with endotracheal tubes of 4.5 mm ID |
| 20851334007081 | AirWave Sensor - Pediatric Small - for use with endotracheal tubes of 4.0 mm ID |
| 00851334007070 | AirWave Reusable Sensor Cable - for Use with All Sizes of the AirWave Sensor |
| 20851334007067 | AirWave Sensor - Neonatal Large - for use with endotracheal tubes of 3.5 mm ID |
| 20851334007050 | AirWave Sensor - Neonatal Medium - for use with endotracheal tubes of 3.0 mm ID |
| 20851334007043 | AirWave Sensor - Neonatal Small - for use with endotracheal tubes of 2.5 mm ID |
| 20851334007036 | AirWave Sensor - Adult Large - for use with endotracheal tubes of 8.5 or 9.0 mm ID |
| 20851334007029 | AirWave Sensor - Adult Medium - for use with endotracheal tubes of 7.5 or 8.0 mm ID |
| 20851334007012 | AirWave Sensor - Adult Small - for use with endotracheal tubes of 6.5 or 7.0 mm ID |
| 00851334007001 | AirWave Monitor - Portable/handheld monitor packaged with power transformer and electrical cord, |
| 00851334007292 | AirWave Reusable Sensor Cable - for Use with All Sizes of the AirWave Sensor |
| 10851334007282 | Adult SonarMed Sensor - for use with endotracheal tubes of 8.5 or 9.0 mm ID |
| 00851334007261 | Adult SonarMed Sensor - for use with endotracheal tubes of 7.5 or 8.0 mm ID |
| 10851334007251 | Adult SonarMed Sensor - for use with endotracheal tubes of 6.5 or 7.0 mm ID |
| 10851334007244 | Pediatric SonarMed Sensor - for use with endotracheal tubes of 5.5 or 6.0 mm ID |
| 10851334007237 | Pediatric SonarMed Sensor - for use with endotracheal tubes of 5.0 mm ID |
| 10851334007220 | Pediatric SonarMed Sensor - for use with endotracheal tubes of 4.5 mm ID |
| 10851334007213 | Pediatric SonarMed Sensor - for use with endotracheal tubes of 4.0 mm ID |
| 10851334007206 | Neonatal SonarMed Sensor - for use with endotracheal tubes of 3.5 mm ID |
| 10851334007190 | Neonatal SonarMed Sensor - for use with endotracheal tubes of 3.0 mm ID |
| 10851334007183 | Neonatal SonarMed Sensor - for use with endotracheal tubes of 2.5 mm ID |