FDA.reportPublic FDA data

MediByte Patient Kit

Primary DI
B1408111251
Brand
MediByte Patient Kit
Company
Braebon Medical Corporation
Model
8111-25
Catalog number
8111-25
Device description
Consumables to be used with the MediByte. The single-use kit contains: 8599 Oral + Nasal Cannula with Filter and Paper Tape.
Published
2025-05-02
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
B1408111251PrimaryHIBCC0
B14081110Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Gas-sampling/monitoring respiratory tubing, single-useA length of flexible noninvasive tube(s) primarily intended to be connected between a tube/mask breathing circuit connector and a respiratory gas measuring instrument [e.g., a carbon dioxide (CO2) or multi-gas analyser, manometer/pressure monitor] for gas pressure or flow monitoring and/or gas sampling; a microbial filter may be included. It is not intended for delivery of medical gas to the patient and does not include a patient mask or nasal cannula. This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
888.462.4841info@braebon.com

Regulatory Flags#

DUNS number
251731105
Device count
25
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
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
B1408620601BRAEBON Leadwire Kit8620-608620-602024-09-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10197344155125MEDLINEMEDLINE INDUSTRIES, INC.CAT2026-01-29
10197344158478HUDSON RCIMEDLINE INDUSTRIES, INC.CAT2025-10-17
10197344158409HUDSON RCIMEDLINE INDUSTRIES, INC.CAT2025-09-26
10197344158416HUDSON RCIMEDLINE INDUSTRIES, INC.CAT2025-09-26
10197344158423HUDSON RCIMEDLINE INDUSTRIES, INC.CAT2025-09-26
10197344158430HUDSON RCIMEDLINE INDUSTRIES, INC.CAT2025-09-26
10197344158447HUDSON RCIMEDLINE INDUSTRIES, INC.CAT2025-09-26
10197344158454HUDSON RCIMEDLINE INDUSTRIES, INC.CAT2025-09-26
10197344158461HUDSON RCIMEDLINE INDUSTRIES, INC.CAT2025-09-12
10197344161164MEDLINEMEDLINE INDUSTRIES, INC.CAT2025-09-12
10197344161171MEDLINEMEDLINE INDUSTRIES, INC.CAT2025-09-12
10197344161188MEDLINEMEDLINE INDUSTRIES, INC.CAT2025-09-12
10197344161195MEDLINEMEDLINE INDUSTRIES, INC.CAT2025-09-12
10197344161201MEDLINEMEDLINE INDUSTRIES, INC.CAT2025-09-12
10197344161218MEDLINEMEDLINE INDUSTRIES, INC.CAT2025-09-12
10197344161225MEDLINEMEDLINE INDUSTRIES, INC.CAT2025-09-12
10197344161232MEDLINEMEDLINE INDUSTRIES, INC.CAT2025-09-12
10197344155064MEDLINEMEDLINE INDUSTRIES, INC.CAT2025-08-21
10197344155101MEDLINEMEDLINE INDUSTRIES, INC.CAT2025-08-21
10197344158522MEDLINEMEDLINE INDUSTRIES, INC.CAT2025-08-21
10197344009664HUDSON RCIMEDLINE INDUSTRIES, INC.CAT2025-05-13
10197344009985HUDSON RCIMEDLINE INDUSTRIES, INC.CAT2025-05-13
10197344010004HUDSON RCIMEDLINE INDUSTRIES, INC.CAT2025-05-13
10197344011254HUDSON RCIMEDLINE INDUSTRIES, INC.CAT2025-05-13
10197344011261HUDSON RCIMEDLINE INDUSTRIES, INC.CAT2025-05-13
10197344042210HUDSON RCIMEDLINE INDUSTRIES, INC.CAT2025-05-13
10197344042227HUDSON RCIMEDLINE INDUSTRIES, INC.CAT2025-05-13
10197344102099MEDLINEMEDLINE INDUSTRIES, INC.CAT2024-08-15
10197344099832MEDLINEMEDLINE INDUSTRIES, INC.CAT2024-08-07
10197344099849MEDLINEMEDLINE INDUSTRIES, INC.CAT2024-08-07