BEUDAMED

FDA UDI In Commercial Distribution 🇺🇸 United States

BRAEBON Electrode Box SE

DI: B14086120 · Model: 8612 · Braebon Medical Corporation

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Product Codes

1

GMDN Terms

1

Identifiers

1

Pkg Device Count

1

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Basic Information

Brand Name: BRAEBON Electrode Box SE
Primary DI: B14086120
Version / Model: 8612
Catalog Number: 8612
Company Name: Braebon Medical Corporation
Labeler DUNS: 251731105
Distribution Status: In Commercial Distribution
Device Count in Pkg: 1
Record Status: Published
Publish Date: 2019-10-18
Public Version: 1
Public Version Date: 2019-10-28
Public Version Status: New
Public Device Record Key: 8c1e3b63-1905-4ce4-9f18-1e2aee3b39eb

Device Description

The Electrode Box SE, which plugs into the AUX port on the MediByte®, attaches electrodes to the MediByte.

Device Characteristics

Single Use: No
Prescription Use (Rx): Yes
Over the Counter (OTC): No
Kit: No
Combination Product: No
HCT/P: No
Contains NRL: No
Not Made with NRL: No
MRI Safety: Labeling does not contain MRI Safety Information
Direct Marking Exempt: No
PM Exempt: No
Has Serial Number: Yes
Has Lot/Batch Number: No
Has Manufacturing Date: Yes
Has Expiration Date: No
Has Donation ID: No

Sterilization

Is Sterile: No
Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
MNR	Ventilatory Effort Recorder	Anesthesiology	868.2375	2

GMDN Terms

Code	Name	Definition	Implantable	Status
32521	Multiple physiological signal amplifier	An 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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	B14086120	HIBCC

Customer Contacts

Phone: 613.831.6690
Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K061764	000

Storage Conditions

Type: Storage Environment Temperature
Temperature Range: 0 – 60 Degrees Celsius
Type: Storage Environment Humidity
Temperature Range: 10 – 95 Percent (%) Relative Humidity