BRAEBON MediByte Jr. MBJR-W

GUDID B140MBJRU0

The MediByte Jr. is a portable sleep data recorder used to record physiological signals during sleep while the patient is either at home or in a clini

Braebon Medical Corporation

Polysomnograph
Primary Device IDB140MBJRU0
NIH Device Record Keyf4fd375c-f199-4ee1-8617-36ed13dc046b
Commercial Distribution StatusIn Commercial Distribution
Brand NameBRAEBON MediByte Jr.
Version Model NumberMBJR
Catalog NumberMBJR-W
Company DUNS251731105
Company NameBraebon Medical Corporation
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
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

Phone613.831.6690
Emailinfo@braebon.com
Phone613.831.6690
Emailinfo@braebon.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 0 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB140MBJRU0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MNRVentilatory Effort Recorder

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2017-11-13

On-Brand Devices [BRAEBON MediByte Jr. ]

B140MBJRWN0The MediByte Jr. is a portable sleep data recorder used to record physiological signals during s
B140MBJRW0The MediByte Jr. is a portable sleep data recorder used to record physiological signals during s
B140MBJRU0The MediByte Jr. is a portable sleep data recorder used to record physiological signals during s

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