BRAEBON Ultima High-Output PVDF Respiratory Effort 0528

GUDID B14005280

Pneumograph Pneumograph

Primary Device ID	B14005280
NIH Device Record Key	abc1ee6e-5856-497e-b640-f75d78283577
Commercial Distribution Status	In Commercial Distribution
Brand Name	BRAEBON Ultima High-Output PVDF Respiratory Effort
Version Model Number	0528
Catalog Number	0528
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	B14005280 [Primary]

BZQ	Monitor, Breathing Frequency

Steralize Prior To Use	false
Device Is Sterile	false

B14005290	PVDF Respiratory effort sensor is intended for use during sleep disorder studies as a qualitativ
B14005280	PVDF Respiratory effort sensor is intended for use during sleep disorder studies as a qualitativ