Primary Device ID | B1408115251 |
NIH Device Record Key | 9871fb03-4744-44e1-9cce-458b39f9e813 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | MediByte Patient Kit |
Version Model Number | 8115-25 |
Catalog Number | 8115-25 |
Company DUNS | 251731105 |
Company Name | Braebon Medical Corporation |
Device Count | 25 |
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 | B140811150 [Unit of Use] |
HIBCC | B1408115251 [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 | 2019-11-18 |
Device Publish Date | 2019-11-08 |
B1408120251 | Consumables to be used with the MediByte. The single-use kit contains: Nonin Flexiwrap Probe Tap |
B140811951 | Consumables to be used with the MediByte. The single-use kit contains: 3.6 V 1/2 AA Lithium Batt |
B1408115251 | Consumables to be used with the MediByte. The single-use kit contains: 3.6 V 1/2 AA Lithium Batt |
B1408110251 | Consumables to be used with the MediByte. The single-use kit contains: 8597 Oronasal cannula and |
B140811190 | Consumables to be used with the MediByte. The single-use kit contains: 3.6 V 1/2 AA Lithium Batt |
B14081119X0 | Consumables to be used with the MediByte. The single-use kit contains: 3.6 V 1/2 AA Lithium Batt |