| Primary Device ID | B14086110 |
| NIH Device Record Key | b4316f10-cf86-44cd-92b0-7b64ac032751 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | BRAEBON Electrode Box |
| Version Model Number | 8611 |
| Catalog Number | 8611 |
| 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 |
| 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 | B14086110 [Primary] |
| MNR | Ventilatory Effort Recorder |
| 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 |
| 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 |
| B1400572AL0 - BRAEBON Q-RIP Belt for Alice, Large | 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 |
| B1400572APED0 - BRAEBON Q-RIP Belt, Pediatric | 2024-04-02 Pediatric belt for the Q-RIP™ Respiratory Effort System™ which is intended for use during sleep disorder studies as a measur |
| B1400573A0 - Q-RIP to Belt Controller Cable for Alice | 2024-04-02 Cable for the Q-RIP™ Respiratory Effort System™ which is intended for use during sleep disorder studies as a measure of resp |
| B1408592A0 - Q-RIP to Belt Controller Cable for Alice | 2024-04-02 Cable for Disposable RIP Belt which is intended for use during sleep disorder studies as a measure of respiratory effort for rec |
| B1400585PESXA0 - BRAEBON Ultima Esophageal Pressure Transducer | 2024-01-15 Ultima Pressure Transducers are for use during sleep disorder studies as a measure of respiratory airflow (hypopneas and apneas) |
| B14081119X0 - MediByte Patient Kit | 2024-01-08 Consumables to be used with the MediByte. The single-use kit contains: 3.6 V 1/2 AA Lithium Battery, 8597 Oronasal cannula and P |