BRAEBON PT2 Dual Differntial Airflow Pressure Kit 0580D

GUDID B1400580D0

Ultima Pressure Transducers are for use during sleep disorder studies as a measure of respiratory airflow (hypopneas and apneas) and/ or esophageal pr

Braebon Medical Corporation

Air/gas pressure transducer
Primary Device IDB1400580D0
NIH Device Record Key51a75a12-ad04-4c25-bd19-316d5d92de10
Commercial Distribution StatusIn Commercial Distribution
Brand NameBRAEBON PT2 Dual Differntial Airflow Pressure Kit
Version Model Number0580D
Catalog Number0580D
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 Kittrue
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 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
Storage Environment TemperatureBetween 0 Degrees Celsius and 60 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB1400580D0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

BZQMonitor, Breathing Frequency

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 Date2016-09-22

On-Brand Devices [BRAEBON PT2 Dual Differntial Airflow Pressure Kit]

B1400580D0Ultima Pressure Transducers are for use during sleep disorder studies as a measure of respirator
B1400580A0Ultima Pressure Transducers are for use during sleep disorder studies as a measure of respirator

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