MediByte Patient Kit 8115-25

GUDID B1408115251

Consumables to be used with the MediByte. The single-use kit contains: 3.6 V 1/2 AA Lithium Battery, 8597 Oronasal cannula.

Braebon Medical Corporation

Gas-sampling/monitoring respiratory tubing, single-use
Primary Device IDB1408115251
NIH Device Record Key9871fb03-4744-44e1-9cce-458b39f9e813
Commercial Distribution StatusIn Commercial Distribution
Brand NameMediByte Patient Kit
Version Model Number8115-25
Catalog Number8115-25
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
HIBCCB140811150 [Unit of Use]
HIBCCB1408115251 [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

On-Brand Devices [MediByte Patient Kit]

B1408120251Consumables to be used with the MediByte. The single-use kit contains: Nonin Flexiwrap Probe Tap
B140811951Consumables to be used with the MediByte. The single-use kit contains: 3.6 V 1/2 AA Lithium Batt
B1408115251Consumables to be used with the MediByte. The single-use kit contains: 3.6 V 1/2 AA Lithium Batt
B1408110251Consumables to be used with the MediByte. The single-use kit contains: 8597 Oronasal cannula and
B140811190Consumables to be used with the MediByte. The single-use kit contains: 3.6 V 1/2 AA Lithium Batt
B14081119X0Consumables to be used with the MediByte. The single-use kit contains: 3.6 V 1/2 AA Lithium Batt

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