Device
The QT ECG Disposable Electrode Strip is a self-adhesive, single-use, one-piece integrated ECG electrode meant to use with QT ECG recorder. The design of the prepositioned Electrod...
Manufacturer
Qt Medical, Inc.
Qt Medical, Inc.
Model: QTEOS124U
DI: 04719872982005
Status: New
MRI: MR Unsafe
Single-use: Yes
Rx: Yes
OTC: No
First Published: 2026-04-30
Current Version: 2026-05-08
Description
The QT ECG Disposable Electrode Strip is a self-adhesive, single-use, one-piece integrated ECG electrode meant to use with QT ECG recorder. The design of the prepositioned Electrode Strip gives the user an easy way of applying the collection of electrodes in their correct locations, thereby reducing electrode placement errors.
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
7ca603a5-a7b2-4ce0-994d-cc4decea8572
Distribution Status:
In Commercial Distribution
DUNS Number:
078875059
Device Count:
1
DM Exempt:
No
Premarket Exempt:
Yes
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
Yes
Serial Number Tracked:
No
Manufacturing Date Tracked:
Yes
Expiration Date Tracked:
Yes
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
Yes
Identifiers
Device ID:
04719872982005
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 35035
Name: Electrocardiographic electrode, single-use
Definition:
A non-sterile, noninvasive electrical conductor designed to conduct electrical signals, generated by a patient's heart, from the skin surface to an electrocardiograph (ECG) monitoring device, via an ECG lead wire (not included). It is typically a disk-like electrode that is affixed to the skin with a special adhesive, adhesive tape, or suction mechanism; a conductive gel may be pre-applied and it may include a skin cleaning wipe to assist electrical connection. Electrocardiography is usually performed using a set of electrodes (e.g., 10) connected to appropriate leads and cables. This is a single-use device.
FDA Product Codes
DRX
Electrode, Electrocardiograph
Environmental Conditions
Item #1 - Storage Handling Low - @attributes - Unit:
KiloPascal
Item #1 - Storage Handling Low - @attributes - Value:
70
Item #1 - Storage Handling High - @attributes - Unit:
KiloPascal
Item #1 - Storage Handling High - @attributes - Value:
106
Item #1 - Storage Handling Type:
Storage Environment Atmospheric Pressure
Item #2 - Storage Handling Low - @attributes - Unit:
Percent (%) Relative Humidity
Item #2 - Storage Handling Low - @attributes - Value:
10
Item #2 - Storage Handling High - @attributes - Unit:
Percent (%) Relative Humidity
Item #2 - Storage Handling High - @attributes - Value:
93
Item #2 - Storage Handling Type:
Storage Environment Humidity
Item #3 - Storage Handling Low - @attributes - Unit:
Degrees Celsius
Item #3 - Storage Handling Low - @attributes - Value:
5
Item #3 - Storage Handling High - @attributes - Unit:
Degrees Celsius
Item #3 - Storage Handling High - @attributes - Value:
30
Item #3 - Storage Handling Type:
Storage Environment Temperature