| Primary Device ID | B1400580NOX0 |
| NIH Device Record Key | 5067894f-87c4-4014-a9ae-882a355aa6fc |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | BRAEBON Pressure Sensor-NOX |
| Version Model Number | 0580-NOX |
| Catalog Number | 0580-NOX |
| 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 | true |
| 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 |
| 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 |
| Storage Environment Temperature | Between 0 Degrees Celsius and 60 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | B1400580NOX0 [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 |
| 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. |
| B1408620720 - BRAEBON Leadwire Kit | 2024-09-23 Leads for connecting electrodes to a PSG. |
| B1400532XA0 - BRAEBON Ultima Body Position Sensor | 2024-07-22 Five-position sensor to accurately record body position during sleep studies. |
| B1400533XA0 - BRAEBON Ultima Body Position Sensor for Alice 5 | 2024-07-22 Five-position sensor to accurately record body position during sleep studies. |
| B140BM55940 - Divided Nasal Cannula | 2024-07-22 Tubing used to detect airflow in sleep studies. |
| B1400514A0 - BRAEBON cTherm Cannula Thermistor for Alice PDX | 2024-04-02 Cannula thermistor intended for use during sleep disorders studies as a qualitative measure of respiratory airflow for recording |
| B1400572A0 - BRAEBON Q-RIP Belt for Alice | 2024-04-02 Belt for the Q-RIP™ Respiratory Effort System™ which is intended for use during sleep disorder studies as a measure of respi |