braebon.comMEDIBYTE, MODEL MP8
BRAEBON MEDICAL CORP.
BRAEBON MEDICAL CORP.
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3002912391 | 3002912391 | BRAEBON MEDICAL CORP. | 1 | N | 2026-01-01 | 1-100 SCHNEIDER ROAD KANATA Ontario CA K2K 1Y2 |
GUDID Contact Samples#
| Source GUDID | Product | Phone | |
|---|---|---|---|
| B1400580A1 | BRAEBON PT1 Low Gain/ Hi Pressure Transducer Kit for Alice - Ultima Pressure Transducers are for use during sleep disorder studies as a measure of respiratory airflow (hypopneas and apneas) and/ or esophageal pressure for recording onto a data acquisition system. Kit contains 1 Ultima Pressure Sensor; 1 Interface Cable for Alice 6. | 613.831.6690 | info@braebon.com |
| B1400580AXA0 | BRAEBON PT1 Low Gain/ Hi Pressure Transducer Kit for Alice - Ultima Pressure Transducers are for use during sleep disorder studies as a measure of respiratory airflow (hypopneas and apneas) and/ or esophageal pressure for recording onto a data acquisition system. Kit contains 1 Ultima Pressure Sensor; 1 Interface Cable for Alice 6. | 613.831.6690 | info@braebon.com |
| B1400580D0 | BRAEBON PT2 Dual Differntial Airflow Pressure Kit - Ultima Pressure Transducers are for use during sleep disorder studies as a measure of respiratory airflow (hypopneas and apneas) and/ or esophageal pressure for recording onto a data acquisition system. Kit contains 1 Ultima Dual Pressure Sensor; 2 Micro Nasal Cannulae; 2 Oral + Nasal Cannulae. | 613.831.6690 | info@braebon.com |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 57705 | 1583908693 | K984431 | ULTIMA AIRFLOW PRESSURE SENSOR | BZQ | 1998-12-30 |
| 57705 | 1385117283 | K982216 | ULTIMA RESPIRATORY EFFORT SENSOR MODELS 0520 AND 0522 | BZQ | 1998-09-11 |
| 57705 | 1041754926 | K981969 | ULTIMA BODY POSITION SENSOR | LEL | 1998-08-20 |
| 57705 | 1197113164 | K981445 | ULTIMA AIRFLOW SENSOR, 0510 | BZQ | 1998-10-05 |
| 57705 | 1843732134 | K973038 | ADJUSTABLE THERASNORE | LRK | 1997-11-12 |
| 57705 | 1870078681 | K082849 | SILENT SLEEP | LRK | 2009-07-16 |
| 57705 | 1685067629 | K061764 | MEDIBYTE, MODEL MP8 | MNR | 2006-09-06 |
| 57705 | 1447975120 | K042161 | ANTI-SNORING/SLEEP APNEA DEVICE | LRK | 2004-10-27 |
| 57705 | 1521939683 | K031202 | MEDIPALM-20 | OLV | 2003-05-01 |
| 57705 | 1679151144 | K020312 | ULTIMA SNORING MIKE, MODEL 0540 | MNR | 2002-08-07 |
| 57705 | 1158188891 | K001743 | ULTIMA SMARTBELT, MODEL 0560 | BZQ | 2000-08-25 |
| 57705 | 1001149585 | ||||
| 57705 | 1363433907 | ||||
| 57705 | 1406121446 | ||||
| 57705 | 1468201514 | ||||
| 57705 | 2001534101 |
Product Codes Associated With Registrations#
PMN#
MEDIPALM-20
BRAEBON MEDICAL CORP.
ULTIMA SNORING MIKE, MODEL 0540
BRAEBON MEDICAL CORP.
ULTIMA SMARTBELT, MODEL 0560
BRAEBON MEDICAL CORP.
ULTIMA AIRFLOW PRESSURE SENSOR
BRAEBON MEDICAL CORP.
ULTIMA AIRFLOW SENSOR, 0510
BRAEBON MEDICAL CORP.
ULTIMA RESPIRATORY EFFORT SENSOR MODELS 0520 AND 0522
BRAEBON MEDICAL CORP.
ULTIMA BODY POSITION SENSOR
BRAEBON MEDICAL CORP.
GUDID#
BRAEBON Ultima Esophageal Pressure Transducer - Ultima Pressure Transducers are for use during sleep disorder studies as a measure of respiratory airflow (hypopneas and apneas) and/ or esophageal pressure for recording onto a data acquisition system. Kit contains Ultima Dual Pressure Sensor; 2 Dual Pressure Sensor Safety Filter + Adapter; 2 Esophageal Balloon Catheters; 2 Micro Cannulae; 2 Oral + Nasal Cannulae.
2026-03-06
BRAEBON Ultima Airflow Pressure Kit - Ultima Pressure Transducers are for use during sleep disorder studies as a measure of respiratory airflow (hypopneas and apneas) and/ or esophageal pressure for recording onto a data acquisition system. Kit contains Pressure Sensor; Pneumo Flow Sensor; Dual 1 mm Keyhole to Keyhole Cable; Adapter Cable; Dual 1 mm Keyhole male to female cable.
2026-03-06
BRAEBON PT2 Dual Differntial Airflow Pressure Kit - Ultima Pressure Transducers are for use during sleep disorder studies as a measure of respiratory airflow (hypopneas and apneas) and/ or esophageal pressure for recording onto a data acquisition system. Kit contains 1 Ultima Dual Pressure Sensor; 2 Micro Nasal Cannulae; 2 Oral + Nasal Cannulae.
2026-03-06
BRAEBON PT1 Low Gain/ Hi Pressure Transducer Kit for Alice - Ultima Pressure Transducers are for use during sleep disorder studies as a measure of respiratory airflow (hypopneas and apneas) and/ or esophageal pressure for recording onto a data acquisition system. Kit contains 1 Ultima Pressure Sensor; 1 Interface Cable for Alice 6.
2026-03-06
BRAEBON Ultima Esophageal Pressure Transducer - Ultima Pressure Transducers are for use during sleep disorder studies as a measure of respiratory airflow (hypopneas and apneas) and/ or esophageal pressure for recording onto a data acquisition system. Kit contains Ultima Dual Pressure Sensor; 2 Dual Pressure Sensor Safety Filter + Adapter; 2 Esophageal Balloon Catheters; 2 Micro Cannulae; 2 Oral + Nasal Cannulae.
2016-09-22
BRAEBON PT2 Dual Differntial Airflow Pressure Kit - Ultima Pressure Transducers are for use during sleep disorder studies as a measure of respiratory airflow (hypopneas and apneas) and/ or esophageal pressure for recording onto a data acquisition system. Kit contains 1 Ultima Dual Pressure Sensor; 2 Micro Nasal Cannulae; 2 Oral + Nasal Cannulae.
2016-09-22
Ultima Nasal Cannula + Filter - Tubing used to detect airflow in sleep studies.
2019-10-25
BRAEBON PT1 Low Gain/ Hi Pressure Transducer Kit for Alice - Ultima Pressure Transducers are for use during sleep disorder studies as a measure of respiratory airflow (hypopneas and apneas) and/ or esophageal pressure for recording onto a data acquisition system. Kit contains 1 Ultima Pressure Sensor; 1 Interface Cable for Alice 6.
2025-04-30
Oral + Nasal Cannula with Filter - Tubing used to detect airflow in sleep studies.
2025-05-02
MediByte Patient Kit - Consumables to be used with the MediByte. The single-use kit contains: 8599 Oral + Nasal Cannula with Filter and Paper Tape.
2025-05-02
MediByte Patient Kit - Consumables to be used with the MediByte. The single-use kit contains: 8599 Oral + Nasal Cannula with Filter and Paper Tape.
2025-05-02
BRAEBON Interface Cable for Alice 6 - Cable for connecting sensors to a device.
2025-04-30
BRAEBON MediByte Jr. Kit - The MediOX. is a portable sleep data recorder used to record physiological signals during sleep while the patient is either at home or in a clinical environment. Each kit contains 1 MediOX; 1 SpO2 Sensor; 1 Velstretch Strap; 1 USB Cable.
2025-04-28
BRAEBON MediOX - The MediOX is a portable sleep data recorder used to record physiological signals during sleep while the patient is either at home or in a clinical environment.
2025-04-28
BRAEBON PT2 Dual Differntial Airflow Pressure Kit for Alice - Ultima Pressure Transducers are for use during sleep disorder studies as a measure of respiratory airflow (hypopneas and apneas) and/ or esophageal pressure for recording onto a data acquisition system. Kit contains 1 Ultima Dual Pressure Sensor; 2 Interface cables; 1 Pressure Sensor Interface; 2 Micro Cannulae; 2 Oral + Nasal Cannulae.
2016-09-22
Ultima Divided Nasal Cannula + Filter, Pediatric - Tubing used to detect airflow in sleep studies.
2019-10-25
Ultima Divided Nasal Cannula + Filter - Tubing used to detect airflow in sleep studies.
2019-10-25
Divided Nasall Cannula + Filter, Pediatric - Tubing used to detect airflow in sleep studies.
2019-11-08
MediByte Electrode Prep Kit - Consumables to be used with the MediByte. The single-use kit contains: Nonin Flexiwrap Probe Tape, 3.6 V 1/2 AA Lithium Battery, 8597 Oronasal cannula, Snap Electrodes and Snap Electrode Prep Pads.
2019-11-08
BRAEBON Leadwire Kit - Leads for connecting electrodes to a PSG.
2024-09-13
BRAEBON Leadwire Kit - Leads for connecting electrodes to a PSG.
2024-09-13
BRAEBON Leadwire Kit - Leads for connecting electrodes to a PSG.
2024-09-13
BRAEBON Leadwire Kit - Leads for connecting electrodes to a PSG.
2024-09-13
BRAEBON Leadwire Kit - Leads for connecting electrodes to a PSG.
2024-09-13
BRAEBON Leadwire Kit - Leads for connecting electrodes to a PSG.
2024-09-13
BRAEBON Q-RIP Belt, Pediatric - Pediatric belt for the Q-RIP™ Respiratory Effort System™ which is intended for use during sleep disorder studies as a measure of respiratory effort for recording with a data acquisition system. The sensor uses respiratory inductance plethysmography (RIP) technology and plugs directly into an electrode headbox or a DC amplifier.
2024-03-25
BRAEBON Q-RIP Belt for Alice, Large - Belt for the Q-RIP™ Respiratory Effort System™ which is intended for use during sleep disorder studies as a measure of respiratory effort for recording with a data acquisition system. The sensor uses respiratory inductance plethysmography (RIP) technology and plugs directly into an electrode headbox or a DC amplifier.
2024-03-25
BRAEBON Q-RIP Belt for Alice - Belt for the Q-RIP™ Respiratory Effort System™ which is intended for use during sleep disorder studies as a measure of respiratory effort for recording with a data acquisition system. The sensor uses respiratory inductance plethysmography (RIP) technology and plugs directly into an electrode headbox or a DC amplifier.
2024-03-25
Divided Nasal Cannula - Tubing used to detect airflow in sleep studies.
2024-07-12
BRAEBON Ultima Body Position Sensor for Alice 5 - Five-position sensor to accurately record body position during sleep studies.
2024-07-12
BRAEBON Ultima Body Position Sensor - Five-position sensor to accurately record body position during sleep studies.
2024-07-12
Divided Nasal Cannula - Tubing used to detect airflow in sleep studies.
2024-07-12
BRAEBON Ultima Body Position Sensor with 2.5 mm phone connector - Five-position sensor to accurately record body position during sleep studies.
2016-09-22
BRAEBON Ultima Body Position Sensor for Alice 5 - Five-position sensor to accurately record body position during sleep studies.
2016-09-22
BRAEBON Ultima Body Position Sensor - Five-position sensor to accurately record body position during sleep studies.
2016-09-22
BRAEBON Ultima Body Position Sensor - Five-position sensor to accurately record body position during sleep studies.
2016-09-22
BRAEBON Ultima Body Position Sensor - Five-position sensor to accurately record body position during sleep studies.
2016-09-22
BRAEBON Ultima Body Position Sensor - Five-position sensor to accurately record body position during sleep studies.
2016-09-22
BRAEBON Leadwire Kit for MediByte - Leads for connecting electrodes to a MediByte.
2016-09-22
BRAEBON Short Leadwire Kit for MediByte - Leads for connecting electrodes to a MediByte.
2016-09-22