FDA.reportPublic FDA data

BRAEBON SpO2 Cable for MediByte

Primary DI
B14088960
Brand
BRAEBON SpO2 Cable for MediByte
Company
Braebon Medical Corporation
Model
8896
Catalog number
8896
Device description
Finger probe for measuring blood oxygen saturation. Plugs directly into the MediByte.
Published
2016-09-22
Public version status
Update
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
B14088960PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Pulse oximeter probe, reusableA photoelectric device applied externally to a body site, e.g., a fingertip, ear lobe, the bridge of nose, a toe, or the bridge of the foot of a paediatric or adult patient for the transcutaneous measurement of haemoglobin oxygen saturation (SpO2) in arterial blood using light detection. The signals, typically produced by light-emitting diodes (LEDs) and a receiving detector, are received by an oximeter to which this device is connected. The oximeter displays the SpO2 values and may calculate/display other parameters, e.g., electrocardiogram (ECG). This is a reusable device.

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
B140MDO0BRAEBON MediOXMD-OMD-O2025-04-28
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
08720256698340Onera STS 2Onera B.V.MNR2026-05-15
08720256698357Onera STS 2Onera B.V.MNR2026-05-15
08720256698364Onera STS 2Onera B.V.MNR2026-05-15
08720256698371Onera STS 2Onera B.V.MNR2026-05-15
08720256698463Onera STSOnera B.V.MNR2026-05-15
08720256698487Onera STSOnera B.V.MNR2026-05-15
08720256698494Onera STSOnera B.V.MNR2026-05-15
08720256698500Onera STSOnera B.V.MNR2026-05-15
08720256698517Onera STSOnera B.V.MNR2026-05-15
08720256698524Onera STSOnera B.V.MNR2026-05-15
08720256698531Onera STSOnera B.V.MNR2026-05-15
08885021950044TipTraQPRANAQ PTE. LTD.MNR2026-05-15
08885021950051TipTraQPRANAQ PTE. LTD.MNR2026-05-11
B566847001ZmachineGeneral SleepMNR2026-04-09
B566847002ZmachineGeneral SleepMNR2026-04-09
09342451002655Compumedics SomfitCOMPUMEDICS LIMITEDMNR2026-03-12
09342451002662Compumedics SomfitCOMPUMEDICS LIMITEDMNR2026-03-12
09342451002747Compumedics FalconCOMPUMEDICS LIMITEDMNR2026-03-12
09342451002754Compumedics FalconCOMPUMEDICS LIMITEDMNR2026-03-12
09342451002785Compumedics FalconCOMPUMEDICS LIMITEDMNR2026-03-12
09342451002822Compumedics SomfitCOMPUMEDICS LIMITEDMNR2026-03-12
09342451002860Compumedics SomfitCOMPUMEDICS LIMITEDMNR2026-03-12
09342451007063Compumedics Somfit DCOMPUMEDICS LIMITEDMNR2026-03-12