FDA.reportPublic FDA data

EXG Radiolucent Electrode System 4-Lead Electrode

Primary DI
10860009331898
Brand
EXG Radiolucent Electrode System 4-Lead Electrode
Company
CB Innovations, LLC
Model
EXGEES4L
Catalog number
EXGEES4L
Device description
The EXG Radiolucent Electrode with 4-Leads is indicated for use by healthcare professionals for ECG monitoring. This device is disposable, single use, and has been tested for up to 8-hour wear. It may be applied left arm to right arm, right chest to left abdomen, right chest to left chest, or right arm to left abdomen.
Published
2026-03-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DRXElectrode, Electrocardiograph

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DRXElectrode, ElectrocardiographCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10860009331898PackageGS120In Commercial Distribution
00860009331891PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1086000933189810860009331898
00860009331891008600093318918600093318910860009331891

GMDN Terms#

Term, Definition table
TermDefinition
Electrocardiographic electrode, single-useA non-sterile, noninvasive electrical conductor designed to conduct electrical signals, generated by a patient's heart, from the skin surface to an electrocardiograph (ECG) monitoring device, via an ECG lead wire (not included). It is typically a disk-like electrode that is affixed to the skin with a special adhesive, adhesive tape, or suction mechanism; a conductive gel may be pre-applied and it may include a skin cleaning wipe to assist electrical connection. Electrocardiography is usually performed using a set of electrodes (e.g., 10) connected to appropriate leads and cables. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
7608002109info@cboothinnovations.com

Regulatory Flags#

DUNS number
080725301
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860009331808EXG Radiolucent Electrode System 12-Lead ElectrodeEXGEES12LEXGEES12L2026-03-09
00860009331815EXG Radiolucent Electrode System 3-Lead Posterior ElectrodeEXGEES3LEXGEES3L2026-03-09
00860009331891EXG Radiolucent Electrode System 4-Lead ElectrodeEXGEES4LEXGEES4L2026-03-09
10860009331812EXG Radiolucent Electrode System 3-Lead Posterior ElectrodeEXGEES3LEXGEES3L2026-03-09
00860009331853EXG Radiolucent Electrode 5-Lead Cardiac Rhythm ElectrodeEXGEES5LEXGEES5L2026-03-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00851491007555AccuSensorLynn Medical Instrument Co.DRX2026-07-28
00851491007562AccuSensorLynn Medical Instrument Co.DRX2026-07-24
G828HARNESS0PhysiotraceNimbleHeart, Inc.DRX2026-05-28
G828PACKAGE0PhysiotraceNimbleHeart, Inc.DRX2026-05-28
08809083949129TELECTRODEBIOPROTECH INC.DRX2026-04-30
08809083949136TELECTRODEBIOPROTECH INC.DRX2026-04-30
20192253016663KendallCardinal Health 200, LLCDRX2024-02-28
20192253016670KendallCardinal Health 200, LLCDRX2024-02-28
20192253017424KendallCardinal Health 200, LLCDRX2024-02-28
20192253017080KendallCardinal Health 200, LLCDRX2023-03-16
08033003267424NAFIAB SPADRX2021-03-31
20192253016755KendallCardinal Health 200, LLCDRX2021-02-23
20192253017196KendallCardinal Health 200, LLCDRX2020-11-17
08906035281044Ambu WhiteSensorMEDICO ELECTRODES INTERNATIONAL LIMITEDDRX2020-08-20
08906035281174Ambu WhiteSensorMEDICO ELECTRODES INTERNATIONAL LIMITEDDRX2020-08-20
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