EXG Radiolucent Electrode System 12-Lead Electrode

Primary DI
00860009331808
Brand
EXG Radiolucent Electrode System 12-Lead Electrode
Company
CB Innovations, LLC
Model
EXGEES12L
Catalog number
EXGEES12L
Device description
The EXG Radiolucent Electrode System consists of a 12-Lead Electrode and an optional 3-Lead Posterior and Right Sided ECG Electrode. The system has a soft backing with a pressure sensitive adhesive and silver/silver chloride sensing elements.
Published
2026-03-09
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
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
10860009331805PackageGS150In Commercial Distribution
20860009331802PackageGS150In Commercial Distribution
00860009331808PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1086000933180510860009331805
2086000933180220860009331802
00860009331808008600093318088600093318080860009331808

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
760-800-2109info@cboothinnovations.com

Regulatory Flags#

DUNS number
080725301
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
10860009331898EXG Radiolucent Electrode System 4-Lead ElectrodeEXGEES4LEXGEES4L2026-03-09
00860009331853EXG Radiolucent Electrode 5-Lead Cardiac Rhythm ElectrodeEXGEES5LEXGEES5L2026-03-05

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