FDA.reportPublic FDA data

BRAEBON Electrode Box SE

Primary DI
B14086120
Brand
BRAEBON Electrode Box SE
Company
Braebon Medical Corporation
Model
8612
Catalog number
8612
Device description
The Electrode Box SE, which plugs into the AUX port on the MediByte®, attaches electrodes to the MediByte.
Published
2019-10-18
Public version status
New
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
K061764000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K061764000MEDIBYTE, MODEL MP8Braebon Medical Corp.2006-09-06MNR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B14086120PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Multiple physiological signal amplifierAn electronic device that increases current, voltage, or power to adjust the signal level and impedance between two or more medical devices transmitting physiological signals; or the device has the capability of being used for more than a single application, such as electroencephalography (EEG), evoked potential, polysomnography (sleep analysis) and general polygraphy.

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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