PureFlow OroNasal Cannula 0596-50

GUDID B1400596501

Tubing used to detect airflow in sleep studies.

Braebon Medical Corporation

Gas-sampling/monitoring respiratory tubing, single-use Gas-sampling/monitoring respiratory tubing, single-use Gas-sampling/monitoring respiratory tubing, single-use Gas-sampling/monitoring respiratory tubing, single-use Gas-sampling/monitoring respiratory tubing, single-use Gas-sampling/monitoring respiratory tubing, single-use Gas-sampling/monitoring respiratory tubing, single-use Gas-sampling/monitoring respiratory tubing, single-use Gas-sampling/monitoring respiratory tubing, single-use Gas-sampling/monitoring respiratory tubing, single-use Gas-sampling/monitoring respiratory tubing, single-use Gas-sampling/monitoring respiratory tubing, single-use
Primary Device IDB1400596501
NIH Device Record Key2cb89cd7-51e5-435f-a115-283f08a377b6
Commercial Distribution StatusIn Commercial Distribution
Brand NamePureFlow OroNasal Cannula
Version Model Number0596-50
Catalog Number0596-50
Company DUNS251731105
Company NameBraebon Medical Corporation
Device Count50
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
HIBCCB14005960 [Unit of Use]
HIBCCB1400596501 [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 Date2019-11-04
Device Publish Date2019-10-25

Devices Manufactured by Braebon Medical Corporation

B1400514A0 - BRAEBON cTherm Cannula Thermistor for Alice PDX2024-04-02 Cannula thermistor intended for use during sleep disorders studies as a qualitative measure of respiratory airflow for recording
B1400572A0 - BRAEBON Q-RIP Belt for Alice2024-04-02 Belt for the Q-RIP™ Respiratory Effort System™ which is intended for use during sleep disorder studies as a measure of respi
B1400572AL0 - BRAEBON Q-RIP Belt for Alice, Large2024-04-02 Belt for the Q-RIP™ Respiratory Effort System™ which is intended for use during sleep disorder studies as a measure of respi
B1400572APED0 - BRAEBON Q-RIP Belt, Pediatric2024-04-02 Pediatric belt for the Q-RIP™ Respiratory Effort System™ which is intended for use during sleep disorder studies as a measur
B1400573A0 - Q-RIP to Belt Controller Cable for Alice2024-04-02 Cable for the Q-RIP™ Respiratory Effort System™ which is intended for use during sleep disorder studies as a measure of resp
B1408592A0 - Q-RIP to Belt Controller Cable for Alice2024-04-02 Cable for Disposable RIP Belt which is intended for use during sleep disorder studies as a measure of respiratory effort for rec
B1400585PESXA0 - BRAEBON Ultima Esophageal Pressure Transducer2024-01-15 Ultima Pressure Transducers are for use during sleep disorder studies as a measure of respiratory airflow (hypopneas and apneas)
B14081119X0 - MediByte Patient Kit2024-01-08 Consumables to be used with the MediByte. The single-use kit contains: 3.6 V 1/2 AA Lithium Battery, 8597 Oronasal cannula and P

Trademark Results [PureFlow OroNasal Cannula]

Mark Image

Registration | Serial
Company
Trademark
Application Date
PUREFLOW ORONASAL CANNULA
PUREFLOW ORONASAL CANNULA
77476251 3783227 Live/Registered
Braebon Medical Corporation
2008-05-16
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.