OroNasal Cannula + Filter, Pediatric BM5591-25

GUDID B140BM5591PED251

Tubing used to detect airflow in sleep studies.

Braebon Medical Corporation

Gas-sampling/monitoring respiratory tubing, single-use
Primary Device IDB140BM5591PED251
NIH Device Record Keyf5abebba-1bbe-4199-893c-c9473c3b95bb
Commercial Distribution StatusIn Commercial Distribution
Brand NameOroNasal Cannula + Filter, Pediatric
Version Model NumberBM5591-25
Catalog NumberBM5591-25
Company DUNS251731105
Company NameBraebon Medical Corporation
Device Count25
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone888.462.4841
Emailinfo@braebon.com
Phone888.462.4841
Emailinfo@braebon.com
Phone888.462.4841
Emailinfo@braebon.com
Phone888.462.4841
Emailinfo@braebon.com
Phone888.462.4841
Emailinfo@braebon.com
Phone888.462.4841
Emailinfo@braebon.com
Phone888.462.4841
Emailinfo@braebon.com
Phone888.462.4841
Emailinfo@braebon.com
Phone888.462.4841
Emailinfo@braebon.com
Phone888.462.4841
Emailinfo@braebon.com
Phone888.462.4841
Emailinfo@braebon.com
Phone888.462.4841
Emailinfo@braebon.com

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB140BM5591PED0 [Unit of Use]
HIBCCB140BM5591PED251 [Primary]

FDA Product Code

CATCannula, Nasal, Oxygen

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-11-18
Device Publish Date2019-11-08

Devices Manufactured by Braebon Medical Corporation

B14081110 - MediByte Patient Kit2025-05-12 Consumables to be used with the MediByte. The single-use kit contains: 8599 Oral + Nasal Cannula with Filter and Paper Tape.
B14085990 - Oral + Nasal Cannula with Filter2025-05-12 Tubing used to detect airflow in sleep studies.
B14003760 - BRAEBON Interface Cable for Alice 62025-05-08 Cable for connecting sensors to a device.
B1400580AXA0 - BRAEBON PT1 Low Gain/ Hi Pressure Transducer Kit for Alice2025-05-08 Ultima Pressure Transducers are for use during sleep disorder studies as a measure of respiratory airflow (hypopneas and apneas)
B140MDO0 - BRAEBON MediOX2025-05-06 The MediOX is a portable sleep data recorder used to record physiological signals during sleep while the patient is either at ho
B140MDOK0 - BRAEBON MediByte Jr. Kit2025-05-06 The MediOX. is a portable sleep data recorder used to record physiological signals during sleep while the patient is either at h
B14086201200 - BRAEBON Leadwire Kit2024-09-23 Leads for connecting electrodes to a PSG.
B1408620600 - BRAEBON Leadwire Kit2024-09-23 Leads for connecting electrodes to a PSG.

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.