FDA.reportPublic FDA data

BRAEBON MediOX

Primary DI
B140MDO0
Brand
BRAEBON MediOX
Company
Braebon Medical Corporation
Model
MD-O
Catalog number
MD-O
Device description
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.
Published
2025-04-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MNRVentilatory Effort Recorder

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MNRVentilatory Effort RecorderAnesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K061764000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K061764000MEDIBYTE, MODEL MP8Braebon Medical Corp.2006-09-06MNR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B140MDO0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
PolysomnographA mains electricity (AC-powered) device designed to record physiological signals from a sleeping patient to assess sleep disorders (e.g., insomnia, snoring or sleep apnoea). The device is typically computerized and usually records an electrocardiogram (ECG), electroencephalogram (EEG), chest wall motion, airflow at both the nose and the mouth, eye movements, haemoglobin oxygen saturation (SpO2) and electromyogram (EMG). Parameters may be added or omitted depending on the study being performed. The device includes multiple electrodes/sensors placed on the patient in specific areas as well as amplifiers and filters for recording.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity10 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature0 Degrees Celsius60 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
613.831.6690info@braebon.com

Regulatory Flags#

DUNS number
251731105
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B1400580A1BRAEBON PT1 Low Gain/ Hi Pressure Transducer Kit for Alice0580A0580A2026-03-06
B1400580D1BRAEBON PT2 Dual Differntial Airflow Pressure Kit0580D0580D2026-03-06
B1400580N1BRAEBON Ultima Airflow Pressure Kit0580N0580-NOX2026-03-06
B1400580PES1BRAEBON Ultima Esophageal Pressure Transducer0580PES0580PES2026-03-06
B1400580AXA0BRAEBON PT1 Low Gain/ Hi Pressure Transducer Kit for Alice0580A0580A2025-04-30
B1400582501Ultima Nasal Cannula + Filter0582-500582-502019-10-25
B1400580D0BRAEBON PT2 Dual Differntial Airflow Pressure Kit0580D0580D2016-09-22
B1400580PES0BRAEBON Ultima Esophageal Pressure Transducer0580PES0580PES2016-09-22
B1408111251MediByte Patient Kit8111-258111-252025-05-02
B14081110MediByte Patient Kit8111-258111-252025-05-02
B14085990Oral + Nasal Cannula with Filter859985992025-05-02
B14003760BRAEBON Interface Cable for Alice 6037603762025-04-30
B140MDOK0BRAEBON MediByte Jr. KitMDO-KMDO-K2025-04-28
B1400580A0BRAEBON PT2 Dual Differntial Airflow Pressure Kit for Alice0580A0580A2016-09-22
B1408130201MediByte Electrode Prep Kit8130-208130-202019-11-08
B140BM5598501Divided Nasall Cannula + Filter, PediatricBM5598-50BM5598-502019-11-08
B1400582MCO2501Ultima Divided Nasal Cannula + Filter0582MCO2-500582MCO2-502019-10-25
B1400582MCO2PED501Ultima Divided Nasal Cannula + Filter, Pediatric0582MCO2-PED-500582MCO2-PED-502019-10-25
B14086201201BRAEBON Leadwire Kit8620-1208620-1202024-09-13
B1408620601BRAEBON Leadwire Kit8620-608620-602024-09-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04250413407392Sensor kit for SOMNOscreen (paediatric)SOMNOmedics AGMNR2026-10-10
04250413407408Sensor kit for SOMNOscreen (extra small)SOMNOmedics AGMNR2026-10-10
04250413402380Pneumatic Effort Belt - Size XSSOMNOmedics AGMNR2026-10-09
04250413402397Pneumatic Effort Belt - Size SSOMNOmedics AGMNR2026-10-09
04250413402403Pneumatic Effort Belt - Size MSOMNOmedics AGMNR2026-10-09
04250413402410Pneumatic Effort Belt - Size LSOMNOmedics AGMNR2026-10-09
04250413402427Pneumatic Effort Belt - Size XXLSOMNOmedics AGMNR2026-10-09
04250413410392Wireless PLM/EMG sensor right legSOMNOmedics AGMNR2026-10-08
04250413401635DOMINO lightSOMNOmedics AGMNR2026-10-07
04250413402861EEG-ElectrodeSOMNOmedics AGMNR2026-10-07
04250413404858SOMNOtouch™ RESP ecoSOMNOmedics AGMNR2026-10-07
04250413405664DOMINOSOMNOmedics AGMNR2026-10-07
04250413410385Wireless PLM/EMG sensor left legSOMNOmedics AGMNR2026-10-07
00850063034395Night ShiftADVANCED BRAIN MONITORING, INC.MNR2026-10-05
00850063034500Night ShiftADVANCED BRAIN MONITORING, INC.MNR2026-10-05
00850063034517Night ShiftADVANCED BRAIN MONITORING, INC.MNR2026-10-05
00860000272421Rhythm ExpressVIVAQUANT, INC.MNR2026-10-01
08885021950075TipTraQPRANAQ PTE. LTD.MNR2026-09-25
08885021950105TipTraQPRANAQ PTE. LTD.MNR2026-09-25
04250413410637SOMNOscreen HDSOMNOmedics AGMNR2026-08-13
04250413406388SOMNOwatch™ eco orangeSOMNOmedics AGMNR2026-07-07
04250413405725HomeSleepTestSOMNOmedics AGMNR2026-07-02
04250413405732HomeSleepTest REM+SOMNOmedics AGMNR2026-07-02
08885021950013TipTraQPRANAQ PTE. LTD.MNR2026-05-18
08885021950136TipTraQPRANAQ PTE. LTD.MNR2026-05-18
08720256698296Onera STS 2Onera B.V.MNR2026-05-15
08720256698302Onera STS 2Onera B.V.MNR2026-05-15
08720256698319Onera STS 2Onera B.V.MNR2026-05-15
08720256698326Onera STS 2Onera B.V.MNR2026-05-15
08720256698333Onera STS 2Onera B.V.MNR2026-05-15