FDA.reportPublic FDA data

BRAEBON EKG Eliminator

Primary DI
B14006000
Brand
BRAEBON EKG Eliminator
Company
Braebon Medical Corporation
Model
0600
Catalog number
0600
Device description
Intended to eliminate unwanted EKG artifact from bilateral EMG tracings during overnight sleep recordings.
Published
2023-06-07
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
IKDCable, Electrode

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IKDCable, ElectrodePhysical Medicine2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B14006000PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Electrocardiographic lead set, reusableA collection of noninvasive devices intended to be used to conduct electrical signals from a patient's heart, via an electrode attached to the surface of the chest/limbs, to an electrocardiograph (ECG) machine or a patient monitoring system. It includes an insulated metal wire(s) with a detachable or permanently attached electrode, and may include a cable with connector; some types may be designed as a pre-configured array (e.g., EEG belt) to assist electrode placement. This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
6138316690info@braebon.com

Regulatory Flags#

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

Other Devices From This Company#

Primary DI, Brand, Model table
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B140MDOK0BRAEBON MediByte Jr. KitMDO-KMDO-K2025-04-28
B1400580A0BRAEBON PT2 Dual Differntial Airflow Pressure Kit for Alice0580A0580A2016-09-22
B1408130201MediByte Electrode Prep Kit8130-208130-202019-11-08
B140BM5598501Divided Nasall Cannula + Filter, PediatricBM5598-50BM5598-502019-11-08
B1400582MCO2501Ultima Divided Nasal Cannula + Filter0582MCO2-500582MCO2-502019-10-25
B1400582MCO2PED501Ultima Divided Nasal Cannula + Filter, Pediatric0582MCO2-PED-500582MCO2-PED-502019-10-25
B14086201201BRAEBON Leadwire Kit8620-1208620-1202024-09-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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06946725571736APKAPK Technology Co.,Ltd.IKD2026-08-15
06946725512173APKAPK Technology Co.,Ltd.IKD2026-08-14
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