| Primary Device ID | B14081119X0 |
| NIH Device Record Key | 44620c95-336a-4f5f-b92b-30f78a44ec19 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | MediByte Patient Kit |
| Version Model Number | 8119-25 |
| Catalog Number | 8119-25 |
| 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 | |
| Phone | 888.462.4841 |
| info@braebon.com |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | B14081119X0 [Unit of Use] |
| HIBCC | B1408119252 [Primary] |
| CAT | Cannula, Nasal, Oxygen |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2024-01-08 |
| Device Publish Date | 2023-06-09 |
| 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 |