Primary Device ID | B1408597501 |
NIH Device Record Key | d25e92bc-1d47-4f8d-b855-d8b434f35c5e |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | PureFlow OroNasal Cannula + Filter |
Version Model Number | 8597-50 |
Catalog Number | 8597-50 |
Company DUNS | 251731105 |
Company Name | Braebon Medical Corporation |
Device Count | 50 |
DM Exempt | false |
Pre-market Exempt | true |
MRI Safety Status | Labeling does not contain MRI Safety Information |
Human Cell/Tissue Product | false |
Device Kit | false |
Device Combination Product | false |
Single Use | true |
Lot Batch | true |
Serial Number | false |
Manufacturing Date | true |
Expiration Date | false |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | true |
OTC Over-The-Counter | false |
Phone | 888.462.4841 |
info@braebon.com | |
Phone | 888.462.4841 |
info@braebon.com | |
Phone | 888.462.4841 |
info@braebon.com | |
Phone | 888.462.4841 |
info@braebon.com | |
Phone | 888.462.4841 |
info@braebon.com | |
Phone | 888.462.4841 |
info@braebon.com | |
Phone | 888.462.4841 |
info@braebon.com | |
Phone | 888.462.4841 |
info@braebon.com | |
Phone | 888.462.4841 |
info@braebon.com | |
Phone | 888.462.4841 |
info@braebon.com | |
Phone | 888.462.4841 |
info@braebon.com | |
Phone | 888.462.4841 |
info@braebon.com |
Device Issuing Agency | Device ID |
---|---|
HIBCC | B14085970 [Unit of Use] |
HIBCC | B1408597501 [Primary] |
CAT | Cannula, Nasal, Oxygen |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2019-11-15 |
Device Publish Date | 2019-11-07 |
B1400597501 | Tubing used to detect airflow in sleep studies. |
B1408597501 | Tubing used to detect airflow in sleep studies. |
B140859951 | Tubing used to detect airflow in sleep studies. |
B1408596501 | Tubing used to detect airflow in sleep studies. |