| Primary Device ID | B1400597501 |
| NIH Device Record Key | dce29198-0750-4fc8-8d87-0641837dd75b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | PureFlow OroNasal Cannula + Filter |
| Version Model Number | 0597-50 |
| Catalog Number | 0597-50 |
| 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 | B14005970 [Unit of Use] |
| HIBCC | B1400597501 [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 | 2019-11-04 |
| Device Publish Date | 2019-10-25 |
| 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. |