Ecg

FDA UDI

Class II (US FDA UDI)

by Zoll Medical Corporation

Identity

Trade Name: ECG FDA UDI
Generic Name: Electrocardiographic electrode, single-use FDA UDI
Device Name: 4 ECG RECTANGULAR ELECTRODES, 4 ELECTRODES / POUCH FDA UDI
Model / Reference: 9600-0225 FDA UDI
Description: 4 ECG RECTANGULAR ELECTRODES, 4 ELECTRODES / POUCH FDA UDI

Identifiers

Primary DI / UDI-DI: 00847946022013 FDA UDI
FDA Product Code: DRX FDA UDI
GMDN Term: Electrocardiographic electrode, single-use FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 870.2360 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

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

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Electrocardiographic electrode, single-use

Ecg by Zoll Medical Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Electrocardiographic electrode, single-use.

ECG leadwire — Shenzhen City Teveik Technology Co., Ltd. · Class I
Elektrody EKG — SORIMEX sp. z o.o. · Class I
SWAROMED — TYROLMED GmbH · Class II
SWAROMED — TYROLMED GmbH · Class II
SWAROMED — TYROLMED GmbH · Class II
PG10S /RU26 — FIAB S.p.A. · Class I
Medline — MEDLINE INDUSTRIES, INC. · Class II
Kendall — Cardinalhealth · Class II

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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Zoll Medical Corporation

Sources (1)

FDA UDI 215c7669-3288-4eba-b52b-eba5e2f54997 34 fields · synced Jun 8, 2026