FDA.reportPublic FDA data

Electrically Conductive Gel (ECG)

Primary DI
00616784124018
Brand
Electrically Conductive Gel (ECG)
Company
Dynarex Corporation
Model
1240
Device description
Electrically Conductive Gel (ECG), Conductive, Noncorrosive, Salt & Alcohol Free, Water Soluble
Published
2021-02-10
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
GYBMedia, Electroconductive

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GYBMedia, ElectroconductiveNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K962681000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K962681000ECOGEL 300 TENS GELEco-Med Pharmaceuticals, Inc.1996-10-04GYB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00616784124032PackageGS112In Commercial Distribution
00616784124018PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00616784124032006167841240326167841240320616784124032
00616784124018006167841240186167841240180616784124018

GMDN Terms#

Term, Definition table
TermDefinition
Electrode conductive mediumA non-sterile substance intended to be used as a medium for the efficient transmission of electrical signals between an electrode and the body, and for the reduction of the isolation properties of the skin. It is typically in the form of a gel, paste, spray or cream and is usually used in electrocardiography, defibrillation and diathermy. After application, this device cannot be reused.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
008124539
Device count
1

Other Devices From This Company#

Primary DI, Brand, Model table
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00840117305731Resp-O2 Closed Suction Tracheal Catheter, Double Swivel Elbow (DSE)310112021-04-22
00840117305755Resp-O2 Closed Suction Tracheal Catheter, Double Swivel Elbow (DSE)310122021-04-22
00840117305861Resp-O2 Advantage Respiratory B/V Filter304002021-04-22
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00840117319486Resp-O2 Closed Suction Tracheal Catheter, Double Swivel Elbow (DSE)310132021-04-22
00840117319547Resp-O2 Closed Suction Tracheal Catheters, T-Piece, Pediatric310002021-04-22
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00840117305311Resp-O2 Heat Moisture Exchanger + B/V Filter (HMEF) 1000301042021-04-22
00840117305335Resp-O2 Hygroscopic Condenser Humidifier HMEF 1500301052021-04-22
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Primary DI, Brand, Company table
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