| Primary Device ID | 00860014485220 |
| NIH Device Record Key | 69ea1254-a959-4105-9536-1db1ef8240f5 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Breathewave |
| Version Model Number | Small |
| Company DUNS | 138492599 |
| Company Name | BREATHEWAVE TECHNOLOGIES INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| 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 | false |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | false |
| OTC Over-The-Counter | true |
| Phone | 2019407668 |
| more@breathewave.com | |
| Phone | 2019407668 |
| more@breathewave.com | |
| Phone | 2019407668 |
| more@breathewave.com | |
| Phone | 2019407668 |
| more@breathewave.com | |
| Phone | 2019407668 |
| more@breathewave.com | |
| Phone | 2019407668 |
| more@breathewave.com | |
| Phone | 2019407668 |
| more@breathewave.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00199284007109 [Package] Contains: 00860014485213 Package: [12 Units] In Commercial Distribution |
| GS1 | 00860014485213 [Primary] |
| GS1 | 00860014485220 [Package] Contains: 00860014485213 Package: [3 Units] In Commercial Distribution |
| LWF | Dilator, Nasal |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-12-31 |
| Device Publish Date | 2025-12-23 |
| 00860014485268 | Contoured Nasal Dilator |
| 00860014485244 | Contoured Nasal Dilator |
| 00860014485220 | Contoured Nasal Dilator |
| 00860014485206 | Contoured Nasal Dilator - Starter Pack - 1x S,M,L |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() BREATHEWAVE 98584250 not registered Live/Pending |
Breathewave Technologies Inc. 2024-06-05 |