BRAEBON MediByte Jr. MBJR-W

GUDID B140MBJRW0

Polysomnograph Polysomnograph

Primary Device ID	B140MBJRW0
NIH Device Record Key	c1b1d9f3-fdbb-4541-95b9-8623e6bbe884
Commercial Distribution Status	In Commercial Distribution
Brand Name	BRAEBON MediByte Jr.
Version Model Number	MBJR-W
Catalog Number	MBJR-W
Company DUNS	251731105
Company Name	Braebon Medical Corporation
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	false
Lot Batch	false
Serial Number	true
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

Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between 0 Degrees Celsius and 60 Degrees Celsius
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between 0 Degrees Celsius and 60 Degrees Celsius

Device Issuing Agency	Device ID
HIBCC	B140MBJRW0 [Primary]

MNR	Ventilatory Effort Recorder

Steralize Prior To Use	false
Device Is Sterile	false

B140MBJRWN0	The MediByte Jr. is a portable sleep data recorder used to record physiological signals during s
B140MBJRW0	The MediByte Jr. is a portable sleep data recorder used to record physiological signals during s
B140MBJRU0	The MediByte Jr. is a portable sleep data recorder used to record physiological signals during s