| Primary Device ID | B14085720 |
| NIH Device Record Key | 77b7af6b-bf22-4d47-bf54-012383949611 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | BRAEBON RIP Belt for MediByte |
| Version Model Number | 8572 |
| Catalog Number | 8572 |
| Company DUNS | 251731105 |
| Company Name | Braebon Medical Corporation |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | false |
| Serial Number | true |
| 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 | 613.831.6690 |
| info@braebon.com | |
| Phone | 613.831.6690 |
| info@braebon.com |
| Length | 48 Inch |
| Length | 48 Inch |
| Storage Environment Temperature | Between 0 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | B14085720 [Primary] |
| BZQ | Monitor, Breathing Frequency |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-09-22 |
| B14085720 | Belt intended for use during sleep disorder studies as a measure of respiratory effort for recor |
| B14085920 | Cable for Disposable RIP Belt which is intended for use during sleep disorder studies as a measu |