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Midmark IQecg® Digital ECG

FDA UDI

Class II (US FDA UDI)

by Midmark Corporation

Identity

Trade Name
Midmark IQecg® Digital ECG FDA UDI
Generic Name
Electrocardiograph, professional, multichannel FDA UDI
Device Name
The IQecg®from Midmark is an easy-to-use, digital, 12-lead resting ECG solution that helps you quickly administer testing and access patient information you need to make informed cardiac assessments and provide more efficient patient care. Kit includes: Midmark IQecg - USB Version, 10-Lead Patient Cable, 10-Pack Clear ECG Clips, and 100-Pack Disposable EZ-Trode ECG Electrodes. FDA UDI
Model / Reference
4-000-0061 FDA UDI
Description
The IQecg®from Midmark is an easy-to-use, digital, 12-lead resting ECG solution that helps you quickly administer testing and access patient information you need to make informed cardiac assessments and provide more efficient patient care. Kit includes: Midmark IQecg - USB Version, 10-Lead Patient Cable, 10-Pack Clear ECG Clips, and 100-Pack Disposable EZ-Trode ECG Electrodes. FDA UDI

Identifiers

Catalog Number
4-000-0061 FDA UDI
Primary DI / UDI-DI
00841709100895 FDA UDI
FDA Product Code
DPS FDA UDI
GMDN Term
Electrocardiograph, professional, multichannel FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.2340 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

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

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

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Electrocardiograph, professional, multichannel

Midmark IQecg® Digital ECG by Midmark Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Electrocardiograph, professional, multichannel.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Midmark Corporation

Sources (1)

  • FDA UDI d0588ccc-b60f-4e3a-9f60-b668e5ac41be 37 fields · synced Jun 8, 2026