| Primary Device ID | B14081110 | 
| NIH Device Record Key | fed64239-3ba5-4aae-a811-649afeb19bbd | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | MediByte Patient Kit | 
| Version Model Number | 8111-25 | 
| Catalog Number | 8111-25 | 
| 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 | |
| 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 | B14081110 [Unit of Use] | 
| HIBCC | B1408111251 [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 | 2025-05-12 | 
| Device Publish Date | 2025-05-02 | 
| B1408120251 | Consumables to be used with the MediByte. The single-use kit contains: Nonin Flexiwrap Probe Tap | 
| B140811951 | Consumables to be used with the MediByte. The single-use kit contains: 3.6 V 1/2 AA Lithium Batt | 
| B1408115251 | Consumables to be used with the MediByte. The single-use kit contains: 3.6 V 1/2 AA Lithium Batt | 
| B1408110251 | Consumables to be used with the MediByte. The single-use kit contains: 8597 Oronasal cannula and | 
| B140811190 | Consumables to be used with the MediByte. The single-use kit contains: 3.6 V 1/2 AA Lithium Batt | 
| B14081119X0 | Consumables to be used with the MediByte. The single-use kit contains: 3.6 V 1/2 AA Lithium Batt | 
| B14081110 | Consumables to be used with the MediByte. The single-use kit contains: 8599 Oral + Nasal Cannula |