FDA.reportPublic FDA data

BRAEBON Q-Snor Interface

Primary DI
B14005440
Brand
BRAEBON Q-Snor Interface
Company
Braebon Medical Corporation
Model
0544
Catalog number
0544
Device description
Q-Snor component for use during sleep disorder studies as a measure of snoring for recording onto a data acquisition system.
Published
2016-09-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MNRVentilatory Effort Recorder

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MNRVentilatory Effort RecorderAnesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K020312000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K020312000ULTIMA SNORING MIKE, MODEL 0540Braebon Medical Corp.2002-08-07MNR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B14005440PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Freestanding microphoneA 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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity10 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature0 Degrees Celsius60 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
613.831.6690info@braebon.com

Regulatory Flags#

DUNS number
251731105
Device count
1
Serial number
true
Manufacturing date on label
true

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