FDA Registration
Active
🇨🇦 Canada
BRAEBON MEDICAL CORP.
Reg #: 3002912391
·
FEI: 3002912391
·
Expires 2026
Products
9
Proprietary Names
59
Establishment Types
4
Classifications
9
Registration Details
- Registration Name
- BRAEBON MEDICAL CORP.
- Registration Number
- 3002912391
- FEI Number
- 3002912391
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 1-100 SCHNEIDER ROAD
- City
- KANATA Ontario
- Country
- CA
Regulatory Submissions
- 510(k) Number
- K981445
Owner / Operator
- Firm Name
- BRAEBON MEDICAL CORP.
- Operator Number
- 9041773
- Address
- 1-100 SCHNEIDER ROAD
- City
- KANATA
- State
- Ontario
- Postal Code
- K2K 1Y2
- Country
- CA
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Sleep Appliances With Patient Monitoring | PLC | Class 2 | Dental | No | 2019-05-23 |
| Device, Anti-Snoring | LRK | Class 2 | Dental | No | 2019-05-23 |
| Monitor, Breathing Frequency | BZQ | Class 2 | Anesthesiology | No | 2007-11-20 |
| Ventilatory Effort Recorder | MNR | Class 2 | Anesthesiology | No | 2003-10-17 |
| Cannula, Nasal, Oxygen | CAT | Class 1 | Anesthesiology | No | 2002-06-20 |
| Cleaner, Denture, Mechanical | JER | Class 1 | Dental | No | 2023-08-01 |
| Tape And Bandage, Adhesive | KGX | Class 1 | General Hospital | No | 2023-08-01 |
| Cable, Electrode | IKD | Class 2 | Physical Medicine | No | 2004-09-16 |
| Device, Sleep Assessment | LEL | Class 2 | Neurology | No | 2007-11-20 |
Proprietary Names
ULTIMA AIRFLOW SENSOR
VALUELINE AIRFLOW SENSOR
Adult Airflow Thermocouple
Oral Thermocouple Airflow Sensor
cTherm Cannula Thermistor
Ultima Breath Sensor Interface
Ultima Airflow Sensor for Alice
Disposable cTherm
VALUELINE RESPIRATORY EFFORT SENSOR
ULTIMA RESPIRATORY EFFORT SENSORS
Ultima PVDF Respiratory Effort Sensor
Ultima High-Output PVDF Respiratory Effort Sensor
SnoreByte
VALUELINE PRESSURE TRANSDUCER
ULTIMA AIRFLOW PRESSURE TRANSDUCER
Ultima Pressure Sensor Kit for Alice
Ultima Pressure Sensor Kit
Ultima Titration Sensor Kit
Ultima Esophageal Differential Pressure Transducer
Ultima Dual Pressure Sensor Kit
PT Lite Low Gain Pressure Transducer Starter Kit
PT1 Low Gain/High Gain Pressure Transducer Starter Kit
PT2 Dual Differential Airflow Pressure Transducer
MEDIBYTE
MediByte Jr.
MediOX
ValueFlow Nasal Cannula + Filter
OroNasal Cannula
Ultima Micro Nasal Cannula
ValueFlow Oral + Nasal Cannula + Filter
PureFlow Duo Cannula
Ultima Oral + Nasal Cannula + Filter
Ultima Oral + Nasal Cannula
Pneumo Flow Sensor
Dual Pressure Sensor Safety Filter + Adapter
Ultima Pressure Sensor Hydrophobic Filter
PureFlow OroNasal Cannula
PureFlow OroNasal Cannula + Filter
Ultima Nasal Cannula + Filter
Ultima Divided Nasal Cannula
OrthoFresh
CPAPFresh
Q-RIP SYSTEM
ULTIMA SMARTBELT KIT
Disposable RIP Belt
Q-RIP Belt
Q-RIP Belt for Alice
BRAEBON Paper Tape
ULTIMA SNORING MICROPHONE
VALUELINE SNORE SENSOR
Q-Snor Microphone
Ultima Snoring Sensor
Ultima Snore Microphone for MediByte with Thermistor Input
Ultima Snoring Sensor with Keyhole Connector
Snap Electrodes
EKG ELIMINATOR
Leadwire Kit for MediByte
ULTIMA BODY POSITION SENSOR
Ultima Body Position Sensor for Alice
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)
Manufacture Medical Device
Repack or Relabel Medical Device
Develop Specifications But Do Not Manufacture At This Facility