Electrically Conductive Gel (ECG)

FDA UDI

Class II (US FDA UDI)

by Dynarex Corp.

Identity

Trade Name: Electrically Conductive Gel (ECG) FDA UDI
Generic Name: Electrode conductive medium FDA UDI
Device Name: Electrically Conductive Gel (ECG), Conductive, Noncorrosive , Salt & Alcohol Free, Water Soluble FDA UDI
Model / Reference: 1239 FDA UDI
Description: Electrically Conductive Gel (ECG), Conductive, Noncorrosive , Salt & Alcohol Free, Water Soluble FDA UDI

Identifiers

Primary DI / UDI-DI: 00616784123912 FDA UDI
510(k) Number: K962681 FDA UDI
FDA Product Code: GYB FDA UDI
GMDN Term: Electrode conductive medium FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 882.1275 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Electrode conductive medium

Electrically Conductive Gel (ECG) by Dynarex Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

K962681 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Dynarex Corp.

Sources (1)

FDA UDI 0e8d47d2-b7e8-470a-8f30-e5eeff5fc71e 34 fields · synced Jun 8, 2026