| Primary Device ID | B1400599251 | 
| NIH Device Record Key | 7b50b986-61d1-4040-9ac5-c45c91ea2a29 | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | Ultima Oral + Nasal Cannula + Filter | 
| Version Model Number | 0589-25 | 
| Catalog Number | 0589-25 | 
| Company DUNS | 251731105 | 
| Company Name | Braebon Medical Corporation | 
| Device Count | 25 | 
| 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 | B14005990 [Unit of Use] | 
| HIBCC | B1400599251 [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 | 
| B1400599251 | Tubing used to detect airflow in sleep studies. | 
| B1400589501 | Tubing used to detect airflow in sleep studies. | 
| B1400587501 | Tubing used to detect airflow in sleep studies. | 
| B1408589501 | Tubing used to detect airflow in sleep studies. |