Primary Device ID | B140351950 |
NIH Device Record Key | 1fc25c97-0037-4203-a13c-92027c62ca9f |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | SnoreByte Tray |
Version Model Number | 3519-5 |
Catalog Number | 3519-5 |
Company DUNS | 251731105 |
Company Name | Braebon Medical Corporation |
Device Count | 5 |
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 | 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 | 6138316690 |
info@braebon.com | |
Phone | 6138316690 |
info@braebon.com | |
Phone | 6138316690 |
info@braebon.com | |
Phone | 6138316690 |
info@braebon.com | |
Phone | 6138316690 |
info@braebon.com | |
Phone | 6138316690 |
info@braebon.com | |
Phone | 6138316690 |
info@braebon.com | |
Phone | 6138316690 |
info@braebon.com | |
Phone | 6138316690 |
info@braebon.com | |
Phone | 6138316690 |
info@braebon.com | |
Phone | 6138316690 |
info@braebon.com | |
Phone | 6138316690 |
info@braebon.com | |
Phone | 6138316690 |
info@braebon.com | |
Phone | 6138316690 |
info@braebon.com | |
Phone | 6138316690 |
info@braebon.com |
Device Issuing Agency | Device ID |
---|---|
HIBCC | B140351950 [Unit of Use] |
HIBCC | B140351951 [Primary] |
LRK | Device, Anti-Snoring |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2023-06-19 |
Device Publish Date | 2023-06-09 |
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 |