DEVICE: BRAEBON Q-Snor Microphone (B14005450)

Device Identifier (DI) Information

BRAEBON Q-Snor Microphone
0545
In Commercial Distribution
0545
Braebon Medical Corporation
B14005450
HIBCC

1
251731105 *Terms of Use
Q-Snor microphone for use during sleep disorder studies as a measure of snoring for recording onto a data acquisition system.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
Yes
No
No
No
No

GMDN

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Freestanding microphone A freestanding electroacoustic transducer designed to capture sound waves, usually vocal, and convert them into electrical signals that are amplified typically for various medical communication/recording or patient-assistive applications. It is not permanently attached to or integrated into another device and may operate via wireless technology. It is typically hand held, attached to clothing, or placed in a holder.
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FDA Product Code

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Product Code Product Code Name
MNR Ventilatory Effort Recorder
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
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Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
Storage Environment Temperature: between 0 and 60 Degrees Celsius
Storage Environment Humidity: between 10 and 95 Percent (%) Relative Humidity
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

c474eac4-dc98-4fe9-98fd-8b83cab23f04
March 29, 2018
2
September 22, 2016
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

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No
No
None
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Production Identifier(s) in UDI

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No
Yes
No
Yes
No CLOSE

Customer Contact

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613.831.6690
info@braebon.com
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