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Ecg

FDA UDI

Class II (US FDA UDI)

by Zoll Medical Corporation

Identity

Trade Name
ECG FDA UDI
Generic Name
Rechargeable professional automated external defibrillator FDA UDI
Device Name
1-STEP PATIENT CABLE FOR 12-LEAD ECG WITH LIMB-LEAD AND V-LEAD CABLES (7 FT) FDA UDI
Model / Reference
1001-0031-02 FDA UDI
Description
1-STEP PATIENT CABLE FOR 12-LEAD ECG WITH LIMB-LEAD AND V-LEAD CABLES (7 FT) FDA UDI

Identifiers

Primary DI / UDI-DI
00847946021634 FDA UDI
510(k) Number
K062537 FDA UDI
FDA Product Code
DRT FDA UDI
GMDN Term
Rechargeable professional automated external defibrillator FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.2300 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Rechargeable professional automated external defibrillator

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

Similar devices

Also classified as Rechargeable professional automated external defibrillator.

Cleared under the same submission

K062537 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Zoll Medical Corporation

Sources (1)

  • FDA UDI 98724f23-1d55-4ee7-9828-0da402249715 35 fields · synced Jun 8, 2026