PureFlow OroNasal Cannula + Filter 8597-50

GUDID B1408597501

Tubing used to detect airflow in sleep studies.

Braebon Medical Corporation

Gas-sampling/monitoring respiratory tubing, single-use
Primary Device IDB1408597501
NIH Device Record Keyd25e92bc-1d47-4f8d-b855-d8b434f35c5e
Commercial Distribution StatusIn Commercial Distribution
Brand NamePureFlow OroNasal Cannula + Filter
Version Model Number8597-50
Catalog Number8597-50
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
HIBCCB14085970 [Unit of Use]
HIBCCB1408597501 [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 Date2019-11-15
Device Publish Date2019-11-07

On-Brand Devices [PureFlow OroNasal Cannula + Filter]

B1400597501Tubing used to detect airflow in sleep studies.
B1408597501Tubing used to detect airflow in sleep studies.
B140859951Tubing used to detect airflow in sleep studies.
B1408596501Tubing used to detect airflow in sleep studies.

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