| Primary Device ID | B14003050 | 
| NIH Device Record Key | 1c3ecabe-188d-4035-9836-40d88b9378e7 | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | Paper Tape | 
| Version Model Number | 0305-50 | 
| Catalog Number | 0305-50 | 
| 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 | |
| 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 | B14003050 [Unit of Use] | 
| HIBCC | B1400305501 [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 | 2023-06-19 | 
| Device Publish Date | 2023-06-09 | 
| 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. | 
| Mark Image Registration | Serial | Company Trademark Application Date | 
|---|---|
|  PAPER TAPE  97630586  not registered Live/Pending | MktShare Inc. 2022-10-13 | 
|  PAPER TAPE  77503716  not registered Dead/Abandoned | WhiteHill Oral Technologies, Inc. 2008-06-20 |