BRAEBON Q-Snor Microphone 0545

GUDID B14005450

Q-Snor microphone for use during sleep disorder studies as a measure of snoring for recording onto a data acquisition system.

Braebon Medical Corporation

Freestanding microphone
Primary Device IDB14005450
NIH Device Record Keyc474eac4-dc98-4fe9-98fd-8b83cab23f04
Commercial Distribution StatusIn Commercial Distribution
Brand NameBRAEBON Q-Snor Microphone
Version Model Number0545
Catalog Number0545
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
HIBCCB14005450 [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 Date2016-09-22

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