| Primary Device ID | B1408597501 | 
| NIH Device Record Key | d25e92bc-1d47-4f8d-b855-d8b434f35c5e | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | PureFlow OroNasal Cannula + Filter | 
| Version Model Number | 8597-50 | 
| Catalog Number | 8597-50 | 
| Company DUNS | 251731105 | 
| Company Name | Braebon Medical Corporation | 
| Device Count | 50 | 
| 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 | true | 
| Serial Number | false | 
| Manufacturing Date | true | 
| 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 | 
| Phone | 888.462.4841 | 
| info@braebon.com | |
| Phone | 888.462.4841 | 
| info@braebon.com | |
| Phone | 888.462.4841 | 
| info@braebon.com | |
| Phone | 888.462.4841 | 
| info@braebon.com | |
| Phone | 888.462.4841 | 
| info@braebon.com | |
| Phone | 888.462.4841 | 
| info@braebon.com | |
| Phone | 888.462.4841 | 
| info@braebon.com | |
| Phone | 888.462.4841 | 
| info@braebon.com | |
| Phone | 888.462.4841 | 
| info@braebon.com | |
| Phone | 888.462.4841 | 
| info@braebon.com | |
| Phone | 888.462.4841 | 
| info@braebon.com | |
| Phone | 888.462.4841 | 
| info@braebon.com | 
| Device Issuing Agency | Device ID | 
|---|---|
| HIBCC | B14085970 [Unit of Use] | 
| HIBCC | B1408597501 [Primary] | 
| CAT | Cannula, Nasal, Oxygen | 
| Steralize Prior To Use | false | 
| Device Is Sterile | false | 
| Public Version Status | New | 
| Device Record Status | Published | 
| Public Version Number | 1 | 
| Public Version Date | 2019-11-15 | 
| Device Publish Date | 2019-11-07 | 
| B1400597501 | Tubing used to detect airflow in sleep studies. | 
| B1408597501 | Tubing used to detect airflow in sleep studies. | 
| B140859951 | Tubing used to detect airflow in sleep studies. | 
| B1408596501 | Tubing used to detect airflow in sleep studies. |