FDA.reportPublic FDA data

QT ECG

Primary DI
04719872981961
Brand
QT ECG
Company
Qt Medical, Inc.
Model
QTEOS127U
Device 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.
Published
2026-04-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DRXElectrode, Electrocardiograph

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DRXElectrode, ElectrocardiographCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04719872981961PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04719872981961047198729819614719872981961

GMDN Terms#

Term, Definition table
TermDefinition
Electrocardiographic electrode, single-useA 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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity10 Percent (%) Relative Humidity93 Percent (%) Relative Humidity
Storage Environment Temperature5 Degrees Celsius30 Degrees Celsius
Storage Environment Temperature70 KiloPascal106 KiloPascal

Contacts#

Phone, Email table
PhoneEmail
+1 909 323 0007service@qtmedical.com

Regulatory Flags#

DUNS number
078875059
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04719872981947QT ECGQTEOS125U2026-04-30
04719872981954QT ECGQTEOS126U2026-04-30
04719872981978QT ECGQTEOS121U2026-04-30
04719872981985QT ECGQTEOS122U2026-04-30
04719872981992QT ECGQTEOS123U2026-04-30
04719872982005QT ECGQTEOS124U2026-04-30
04719872982012QHeart SensorQTEOS120U2026-04-30
04719872981640QT ECGQTEOS129U2025-12-30
04719872981893QT ECGPCA-A2102025-12-30
04719872981503QT ECGQTERD1002023-06-08
04719872980261QT ECGPCA-C1012025-10-09
04719872980971QT ECGPCA-C101BL2025-10-09
04719872981701QT ECGPCA-C101BS2025-10-09
04719872981794QT ECGPCA-A1102025-10-09
04719872981589QT ECGPCA-C100BS2025-07-08
04719872981541QT ECGPCA-A1002025-07-08
04719872981558QT ECGPCA-A120L2025-07-08
04719872981565QT ECGPCA-A120S2025-07-08
04719872981572QT ECGPCA-A1302025-07-08
04719872981633QHeart SENSORQTEOS120U2025-07-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00851491007555AccuSensorLynn Medical Instrument Co.DRX2026-07-28
00851491007562AccuSensorLynn Medical Instrument Co.DRX2026-07-24
G828HARNESS0PhysiotraceNimbleHeart, Inc.DRX2026-05-28
G828PACKAGE0PhysiotraceNimbleHeart, Inc.DRX2026-05-28
08809083949129TELECTRODEBIOPROTECH INC.DRX2026-04-30
08809083949136TELECTRODEBIOPROTECH INC.DRX2026-04-30
20192253016663KendallCardinal Health 200, LLCDRX2024-02-28
20192253016670KendallCardinal Health 200, LLCDRX2024-02-28
20192253017424KendallCardinal Health 200, LLCDRX2024-02-28
20192253017080KendallCardinal Health 200, LLCDRX2023-03-16
08033003267424NAFIAB SPADRX2021-03-31
20192253016755KendallCardinal Health 200, LLCDRX2021-02-23
20192253017196KendallCardinal Health 200, LLCDRX2020-11-17
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