| Primary Device ID | B140BM5591PED251 | 
| NIH Device Record Key | f5abebba-1bbe-4199-893c-c9473c3b95bb | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | OroNasal Cannula + Filter, Pediatric | 
| Version Model Number | BM5591-25 | 
| Catalog Number | BM5591-25 | 
| 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 | B140BM5591PED0 [Unit of Use] | 
| HIBCC | B140BM5591PED251 [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 | 2019-11-18 | 
| Device Publish Date | 2019-11-08 | 
| B14081110 - MediByte Patient Kit | 2025-05-12 Consumables to be used with the MediByte. The single-use kit contains: 8599 Oral + Nasal Cannula with Filter and Paper Tape. | 
| B14085990 - Oral + Nasal Cannula with Filter | 2025-05-12 Tubing used to detect airflow in sleep studies. | 
| B14003760 - BRAEBON Interface Cable for Alice 6 | 2025-05-08 Cable for connecting sensors to a device. | 
| B1400580AXA0 - BRAEBON PT1 Low Gain/ Hi Pressure Transducer Kit for Alice | 2025-05-08 Ultima Pressure Transducers are for use during sleep disorder studies as a measure of respiratory airflow (hypopneas and apneas) | 
| B140MDO0 - BRAEBON MediOX | 2025-05-06 The MediOX is a portable sleep data recorder used to record physiological signals during sleep while the patient is either at ho | 
| B140MDOK0 - BRAEBON MediByte Jr. Kit | 2025-05-06 The MediOX. is a portable sleep data recorder used to record physiological signals during sleep while the patient is either at h | 
| B14086201200 - BRAEBON Leadwire Kit | 2024-09-23 Leads for connecting electrodes to a PSG. | 
| B1408620600 - BRAEBON Leadwire Kit | 2024-09-23 Leads for connecting electrodes to a PSG. |