BRAEBON PT2 Dual Differntial Airflow Pressure Kit 0580A

GUDID B1400580A0

Air/gas pressure transducer

Primary Device ID	B1400580A0
NIH Device Record Key	e608084e-5342-44a3-a882-0b31abde91d7
Commercial Distribution Status	In Commercial Distribution
Brand Name	BRAEBON PT2 Dual Differntial Airflow Pressure Kit
Version Model Number	0580A
Catalog Number	0580A
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	true
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 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
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity

Device Issuing Agency	Device ID
HIBCC	B1400580A0 [Primary]

BZQ	Monitor, Breathing Frequency

Steralize Prior To Use	false
Device Is Sterile	false

B1400580D0	Ultima Pressure Transducers are for use during sleep disorder studies as a measure of respirator
B1400580A0	Ultima Pressure Transducers are for use during sleep disorder studies as a measure of respirator