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Qt Ecg

FDA UDI

Class II (US FDA UDI)

by QT Medical, Inc.

Identity

Trade Name
QT ECG FDA UDI
Generic Name
Electrocardiographic electrode, single-use FDA UDI
Device Name
The electrode is disposable with a sensing element and is designed for ECG. It is applied to the surface of the body, single-use only, and disposable. FDA UDI
Model / Reference
QTPOS124U FDA UDI
Description
The electrode is disposable with a sensing element and is designed for ECG. It is applied to the surface of the body, single-use only, and disposable. FDA UDI

Identifiers

Primary DI / UDI-DI
04719872980483 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

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI
MRI Safety
MR Unsafe FDA UDI

Category: Electrocardiographic electrode, single-use

Qt Ecg by QT Medical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Electrocardiographic electrode, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
QT Medical, Inc.

Sources (1)

  • FDA UDI 044ced13-2f1a-4a08-bd88-c148f10655e1 35 fields · synced Jun 6, 2026