FDA.reportPublic FDA data

QT ECG

Primary DI
04719872982555
Brand
QT ECG
Company
Qt Medical, Inc.
Model
PCA-A240
Device description
PCA-A240 QHeart Cable U is used to transmit ECG signals from patients to 12-lead ECG machines for diagnostic purposes. It is compatible with ECG cables (patient leadwires). PCA-A240 QHeart Cable U shall connect with QHeart® Sensor F and the ECG cable of a 12-lead ECG machine. Both are used by health care professionals in hospitals, doctor’s offices and nursing homes.
Published
2026-10-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
IKDCable, Electrode

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IKDCable, ElectrodePhysical Medicine2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04719872982555PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04719872982555047198729825554719872982555

GMDN Terms#

Term, Definition table
TermDefinition
Electrocardiographic lead set, reusableA collection of noninvasive devices intended to conduct electrical signals from a patient's heart, via an electrode attached to the surface of the chest/limbs, to an electrocardiograph (ECG) machine or a patient monitoring system. It is designed as an insulated wire(s), which may additionally include a detachable or permanently attached electrode and/or cable with connector. Some types may be designed as a pre-configured array (e.g., EEG belt) to assist electrode placement. This is a reusable device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature00
Storage Environment Temperature00

Contacts#

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

Regulatory Flags#

DUNS number
078875059
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04719872982296QT ECGQCARD-102026-10-28
04719872982302QT ECGQCARD-10W2026-10-28
04719872982418QT ECGPC-10LB2026-10-28
04719872981947QT ECGQTEOS125U2026-04-30
04719872981954QT ECGQTEOS126U2026-04-30
04719872981961QT ECGQTEOS127U2026-04-30
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
50885380213234KendallCardinal Health 200, LLCIKD2026-10-28
50885380213241KendallCardinal Health 200, LLCIKD2026-10-28
50885380213258KendallCardinal Health 200, LLCIKD2026-10-28
06946725572931APKAPK Technology Co.,Ltd.IKD2026-10-26
06946725502341APKAPK Technology Co.,Ltd.IKD2026-10-22
06946725500989APKAPK Technology Co.,Ltd.IKD2025-07-22
06946725500996APKAPK Technology Co.,Ltd.IKD2025-07-22
06946725501009APKAPK Technology Co.,Ltd.IKD2025-07-22
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06946725501030APKAPK Technology Co.,Ltd.IKD2025-07-22
06946725501047APKAPK Technology Co.,Ltd.IKD2025-07-22
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06946725501221APKAPK Technology Co.,Ltd.IKD2025-07-22
06946725501238APKAPK Technology Co.,Ltd.IKD2025-07-22