FDA.reportPublic FDA data

QT ECG

Primary DI
04719872980339
Brand
QT ECG
Company
Qt Medical, Inc.
Model
PCA-A200
Device description
PCA-A200 Electrode Cable is intended to be used with ECG devices. The Electrode Cable is used to connect electrodes of QT Medical, Inc. placed at appropriate sites on the patient to the Monitor/Defibrillator for general monitoring and/or diagnostic evaluation by healthcare professionals.
Published
2021-07-02
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

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
04719872980339PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04719872980339047198729803394719872980339

GMDN Terms#

Term, Definition table
TermDefinition
Electrical-only medical device connection cable, reusableA non-patient-contact, insulated, electrical cord with a connector (plug) at both ends designed to transmit electrical power and/or signal (data) between medical devices (e.g., to connect a lead, electrical catheter, handpiece, or monitor to a parent device). It is not intended to connect directly to patient-worn electrodes (i.e., it is not a lead), is not intended to connect to the mains (i.e., not a mains power cable), does not generate any type of power and/or signal, and has no additional non-electrical conducting or processing functionality. This is a reusable device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Atmospheric Pressure86 KiloPascal106 KiloPascal
Storage Environment Humidity0 Percent (%) Relative Humidity80 Percent (%) Relative Humidity
Storage Environment Temperature-10 Degrees Celsius40 Degrees Celsius

Sterilization Methods#

Method table
Method

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
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
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
04719872981558QT ECGPCA-A120L2025-07-08
04719872981565QT ECGPCA-A120S2025-07-08
04719872981572QT ECGPCA-A1302025-07-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06978035540010SublimedDongguan Goochain Technology Co., Ltd.IKD2026-06-09
06978035540027SublimedDongguan Goochain Technology Co., Ltd.IKD2026-06-09
06978035540034SublimedDongguan Goochain Technology Co., Ltd.IKD2026-06-09
06978035540041SublimedDongguan Goochain Technology Co., Ltd.IKD2026-06-09
06978035540058SublimedDongguan Goochain Technology Co., Ltd.IKD2026-06-09
06978035540065SublimedDongguan Goochain Technology Co., Ltd.IKD2026-06-09
00850087490122AUVONChangsha Yuhong Trading Co., LtdIKD2026-06-08
00850087490146AUVONChangsha Yuhong Trading Co., LtdIKD2026-06-08
06978035540003SublimedDongguan Goochain Technology Co., Ltd.IKD2026-06-05
00650551006602PMT CORPORATIONPMT CORPORATIONIKD2026-06-01
00650551006619PMT CORPORATIONPMT CORPORATIONIKD2026-06-01
00650551006626PMT CORPORATIONPMT CORPORATIONIKD2026-06-01
04250307612871Adapter cable touchproof for ALM Tubeinomed Medizintechnik GmbHIKD2026-05-29
04250307612888Connection cable for ALM Tubeinomed Medizintechnik GmbHIKD2026-05-29
07613327688788N/ASTRYKER SUSTAINABILITY SOLUTIONS, INC.IKD2026-04-06
07613327643237N/ASTRYKER SUSTAINABILITY SOLUTIONS, INC.IKD2024-08-08
07613327643244N/ASTRYKER SUSTAINABILITY SOLUTIONS, INC.IKD2024-08-08
03664539003559NADIXI MEDICALIKD2022-07-06
03664539003566NADIXI MEDICALIKD2022-07-06
03664539003573NADIXI MEDICALIKD2022-07-06
03664539003580NADIXI MEDICALIKD2022-07-06
03664539003603NADIXI MEDICALIKD2022-07-06
03664539003610NADIXI MEDICALIKD2022-07-06
03664539003627NADIXI MEDICALIKD2022-07-06
03664539003634NADIXI MEDICALIKD2022-07-06
08033695721525NAFIAB SPAIKD2021-07-08
08033695726278NAFIAB SPAIKD2020-06-13
08033695726995NAFIAB SPAIKD2020-06-13
08054242441734NAFIAB SPAIKD2020-06-13
08054953345864NAFIAB SPAIKD2020-06-13