FDA.reportPublic FDA data

Divided Nasal Cannula

Primary DI
BM5594501
Brand
Divided Nasal Cannula
Company
Braebon Medical Corporation
Model
BM5594-50
Catalog number
BM5594-50
Device description
Tubing used to detect airflow in sleep studies.
Published
2024-07-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
CATCannula, Nasal, Oxygen

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CATCannula, Nasal, OxygenAnesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
BM5594501PrimaryHIBCC0
B140BM55940Unit of UseHIBCC0

Contacts#

Phone, Email table
PhoneEmail
888.462.4841info@braebon.com

Regulatory Flags#

DUNS number
251731105
Device count
50
Premarket exempt
true
Lot or batch
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

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Primary DI, Brand, Company table
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