FDA.reportPublic FDA data

Wet Gel Monitoring Electrodes

Primary DI
10857175006132
Brand
Wet Gel Monitoring Electrodes
Company
VECTRACOR INC
Model
V100300
Device description
Wet Gel Electrodes Inner Pack of 5
Published
2016-09-26
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
DRXElectrode, Electrocardiograph

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DRXElectrode, ElectrocardiographCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K030073000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K030073000VERMED A10021 RESTING EKG TAB ELECTRODEVermont Medical, Inc.2003-03-28DRX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00857175006159PackageGS1200In Commercial Distribution
10857175006132PrimaryGS10
00857175006135Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00857175006159008571750061598571750061590857175006159
1085717500613210857175006132
00857175006135008571750061358571750061350857175006135

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.

Regulatory Flags#

DUNS number
828416359
Device count
5
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00857175006029VectraplexECG System3.4.22016-09-26
00857175006166Office Medic6.02017-01-23
10857175006071Plastic Mouthpieces (100)Z-5000-26082016-09-26
008571750060673L Calibration Syringe5000-19175000-19172023-06-07
00857175006173Universal SmartECGAHAZ-7000-05002023-06-07
00857175006043Universal ECGZ-7000-0301Z-7000-03012016-09-24
00857175006012Vectraplex CMSV1007052016-09-26
00857175006050Orbit SpirometerZ-7000-0101Z-7000-01012016-09-24
40857175006096Adhesive Solid Gel Electrodes (pack of 100)Z-5000-19202016-09-26
10857175006088Nose Clips724050-002016-09-26
20857175006085Nose Clips7242005-002017-02-03
00857175006111Holter Prep Kit701900-002016-09-26

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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G828PACKAGE0PhysiotraceNimbleHeart, Inc.DRX2026-05-28
08809083949129TELECTRODEBIOPROTECH INC.DRX2026-04-30
08809083949136TELECTRODEBIOPROTECH INC.DRX2026-04-30
08033003267424NAFIAB SPADRX2021-03-31
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