FDA.reportPublic FDA data

EXG Radiolucent Electrode 5-Lead Cardiac Rhythm Electrode

Primary DI
00860009331853
Brand
EXG Radiolucent Electrode 5-Lead Cardiac Rhythm Electrode
Company
CB Innovations, LLC
Model
EXGEES5L
Catalog number
EXGEES5L
Device description
The EXG Radiolucent Electrode with 5-Leads is indicated for use by healthcare professionals for ECG monitoring. This device is disposable, single use, and has been tested for up to 72-hour wear.
Published
2026-03-05
Public version status
New
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
10860009331850PackageGS150In Commercial Distribution
00860009331853PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1086000933185010860009331850
00860009331853008600093318538600093318530860009331853

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
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
10860009331898EXG Radiolucent Electrode System 4-Lead ElectrodeEXGEES4LEXGEES4L2026-03-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850018561006ECG Patient CableINTERNATIONAL BIOMEDICAL, LTD.DRX2026-10-13
19005531000978SkintactLeonhard Lang GmbHDRX2026-10-12
20885380213202KendallCardinal Health 200, LLCDRX2026-08-18
10850078465006NIKOTRACENIKOMED USADRX2026-08-17
10850078465013NIKOTRACENIKOMED USADRX2026-08-17
10850078465020NIKOTRACENIKOMED USADRX2026-08-17
05060038511034Ambu® WhiteSensor 40554Ambu A/SDRX2026-08-07
00851491007555AccuSensorLynn Medical Instrument Co.DRX2026-07-28
00851491007562AccuSensorLynn Medical Instrument Co.DRX2026-07-24
G828HARNESS0PhysiotraceNimbleHeart, Inc.DRX2026-05-28
G828PACKAGE0PhysiotraceNimbleHeart, Inc.DRX2026-05-28
00860002238500Piccolo MedicalPiccolo Medical, Inc.DRX2026-05-06
08809083949129TELECTRODEBIOPROTECH INC.DRX2026-04-30
08809083949136TELECTRODEBIOPROTECH INC.DRX2026-04-30
00860002238586Piccolo MedicalPiccolo Medical, Inc.DRX2025-11-07
10841522130755Eclipse MiniSPACELABS HEALTHCARE (WASHINGTON), INCDRX2024-06-07
20192253016632KendallCardinal Health 200, LLCDRX2024-02-28
20192253016663KendallCardinal Health 200, LLCDRX2024-02-28
20192253016670KendallCardinal Health 200, LLCDRX2024-02-28
20192253016830KendallCardinal Health 200, LLCDRX2024-02-28
20192253017424KendallCardinal Health 200, LLCDRX2024-02-28
20192253017813KendallCardinal Health 200, LLCDRX2024-02-28
20192253018506Uni-PatchCardinal Health 200, LLCDRX2024-02-28
20192253017080KendallCardinal Health 200, LLCDRX2023-03-16
10841522130298Eclipse ProSPACELABS HEALTHCARE (WASHINGTON), INCDRX2023-02-23
20192253016748KendallCardinal Health 200, LLCDRX2021-05-19
08033003267424NAFIAB SPADRX2021-03-31
20192253016755KendallCardinal Health 200, LLCDRX2021-02-23
20192253017349KendallCardinal Health 200, LLCDRX2021-02-23
20192253017196KendallCardinal Health 200, LLCDRX2020-11-17