SnoreByte Kit 3520-5

GUDID B140035201

Mandible-repositioning/palate-lifting sleep-disordered breathing orthosis

Primary Device ID	B140035201
NIH Device Record Key	36827709-bcb7-4dfa-b188-dfb8544c96dc
Commercial Distribution Status	In Commercial Distribution
Brand Name	SnoreByte Kit
Version Model Number	3520-5
Catalog Number	3520-5
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	true
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

Device Issuing Agency	Device ID
HIBCC	B140035201 [Unit of Use]
HIBCC	B140035202 [Primary]

LRK	Device, Anti-Snoring

Steralize Prior To Use	false
Device Is Sterile	false

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