QT ECG

GUDID 04719872980070

The QT ECG system is a hand-held, cordless 12-lead electrocardiograph (ECG) system with Bluetooth connectivity.

QT MEDICAL, INC.

Electrocardiograph, home-use Electrocardiograph, home-use Electrocardiograph, home-use Electrocardiograph, home-use Electrocardiograph, home-use Electrocardiograph, home-use Electrocardiograph, home-use Electrocardiograph, home-use Electrocardiograph, home-use Electrocardiograph, home-use Electrocardiograph, home-use Electrocardiograph, home-use Electrocardiograph, home-use Electrocardiograph, home-use Electrocardiograph, home-use Electrocardiograph, home-use Electrocardiograph, home-use Electrocardiograph, home-use Electrocardiograph, home-use Electrocardiograph, home-use Electrocardiograph, home-use Electrocardiograph, home-use Electrocardiograph, home-use Electrocardiograph, home-use Electrocardiograph, home-use Electrocardiograph, home-use Electrocardiograph, home-use Electrocardiograph, home-use
Primary Device ID04719872980070
NIH Device Record Key5927204a-afd8-4f67-9026-d05eea8ed5fb
Commercial Distribution StatusIn Commercial Distribution
Brand NameQT ECG
Version Model NumberQTERD100
Company DUNS078875059
Company NameQT MEDICAL, INC.
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Producttrue
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1 909 323 0007
Emailservice@qtmedical.com
Phone+1 909 323 0007
Emailservice@qtmedical.com
Phone+1 909 323 0007
Emailservice@qtmedical.com
Phone+1 909 323 0007
Emailservice@qtmedical.com
Phone+1 909 323 0007
Emailservice@qtmedical.com
Phone+1 909 323 0007
Emailservice@qtmedical.com
Phone+1 909 323 0007
Emailservice@qtmedical.com
Phone+1 909 323 0007
Emailservice@qtmedical.com
Phone+1 909 323 0007
Emailservice@qtmedical.com
Phone+1 909 323 0007
Emailservice@qtmedical.com
Phone+1 909 323 0007
Emailservice@qtmedical.com
Phone+1 909 323 0007
Emailservice@qtmedical.com
Phone+1 909 323 0007
Emailservice@qtmedical.com
Phone+1 909 323 0007
Emailservice@qtmedical.com
Phone+1 909 323 0007
Emailservice@qtmedical.com
Phone+1 909 323 0007
Emailservice@qtmedical.com
Phone+1 909 323 0007
Emailservice@qtmedical.com
Phone+1 909 323 0007
Emailservice@qtmedical.com
Phone+1 909 323 0007
Emailservice@qtmedical.com
Phone+1 909 323 0007
Emailservice@qtmedical.com
Phone+1 909 323 0007
Emailservice@qtmedical.com
Phone+1 909 323 0007
Emailservice@qtmedical.com
Phone+1 909 323 0007
Emailservice@qtmedical.com
Phone+1 909 323 0007
Emailservice@qtmedical.com
Phone+1 909 323 0007
Emailservice@qtmedical.com
Phone+1 909 323 0007
Emailservice@qtmedical.com
Phone+1 909 323 0007
Emailservice@qtmedical.com
Phone+1 909 323 0007
Emailservice@qtmedical.com

Device Dimensions

Depth72 Millimeter
Depth72 Millimeter
Depth72 Millimeter
Height18.6 Millimeter
Width68.02 Millimeter
Depth72 Millimeter
Height18.6 Millimeter
Width68.02 Millimeter
Depth72 Millimeter
Height18.6 Millimeter
Width68.02 Millimeter
Depth72 Millimeter
Height18.6 Millimeter
Width68.02 Millimeter
Depth72 Millimeter
Height18.6 Millimeter
Width68.02 Millimeter
Depth72 Millimeter
Height18.6 Millimeter
Width68.02 Millimeter
Depth72 Millimeter
Height18.6 Millimeter
Width68.02 Millimeter
Depth72 Millimeter
Height18.6 Millimeter
Width68.02 Millimeter
Depth72 Millimeter
Height18.6 Millimeter
Width68.02 Millimeter
Depth72 Millimeter
Height18.6 Millimeter
Width68.02 Millimeter
Depth72 Millimeter
Height18.6 Millimeter
Width68.02 Millimeter
Depth72 Millimeter
Height18.6 Millimeter
Width68.02 Millimeter
Depth72 Millimeter
Height18.6 Millimeter
Width68.02 Millimeter
Depth72 Millimeter
Height18.6 Millimeter
Width68.02 Millimeter
Depth72 Millimeter
Height18.6 Millimeter
Width68.02 Millimeter
Depth72 Millimeter
Height18.6 Millimeter
Width68.02 Millimeter
Depth72 Millimeter
Height18.6 Millimeter
Width68.02 Millimeter
Depth72 Millimeter
Height18.6 Millimeter
Width68.02 Millimeter
Depth72 Millimeter
Height18.6 Millimeter
Width68.02 Millimeter
Depth72 Millimeter
Height18.6 Millimeter
Width68.02 Millimeter
Depth72 Millimeter
Height18.6 Millimeter
Width68.02 Millimeter
Depth72 Millimeter
Height18.6 Millimeter
Width68.02 Millimeter
Depth72 Millimeter
Height18.6 Millimeter
Width68.02 Millimeter
Depth72 Millimeter
Height18.6 Millimeter
Width68.02 Millimeter
Depth72 Millimeter
Height18.6 Millimeter
Width68.02 Millimeter
Depth72 Millimeter
Height18.6 Millimeter
Width68.02 Millimeter
Depth72 Millimeter
Height18.6 Millimeter
Width68.02 Millimeter
Depth72 Millimeter

Operating and Storage Conditions

Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal

Device Identifiers

Device Issuing AgencyDevice ID
GS104719872980018 [Primary]
GS104719872980070 [Package]
Contains: 04719872980018
Package: [1 Units]
In Commercial Distribution
GS104719872980278 [Package]
Contains: 04719872980018
Package: [1 Units]
In Commercial Distribution
GS114719872980077 [Package]
Package: [50 Units]
In Commercial Distribution
GS114719872980275 [Package]
Contains: 04719872980278
Package: [80 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DXHTransmitters And Receivers, Electrocardiograph, Telephone

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-07-24
Device Publish Date2018-12-01

On-Brand Devices [QT ECG]

14719872980145The QT ECG Disposable Electrode Strip is a self-adhesive, single use, one-piece integrated ECG e
14719872980138The QT ECG Disposable Electrode Strip is a self-adhesive, single use, one-piece integrated ECG e
14719872980121The QT ECG Disposable Electrode Strip is a self-adhesive, single use, one-piece integrated ECG e
14719872980114The QT ECG Disposable Electrode Strip is a self-adhesive, single use, one-piece integrated ECG e
04719872980070The QT ECG system is a hand-held, cordless 12-lead electrocardiograph (ECG) system with Bluetoot
04719872980421The QT ECG system is a hand-held, cordless 12-lead electrocardiograph (ECG) system with Bluetoot
04719872980384The QT ECG Disposable Electrode Strip is a self-adhesive, single use, one-piece integrated ECG e
04719872980377The QT ECG Disposable Electrode Strip is a self-adhesive, single use, one-piece integrated ECG e
04719872980360The QT ECG Disposable Electrode Strip is a self-adhesive, single use, one-piece integrated ECG e
04719872980353The QT ECG Disposable Electrode Strip is a self-adhesive, single use, one-piece integrated ECG e
04719872980414The QT ECG system is a hand-held, cordless 12-lead electrocardiograph (ECG) system with Bluetoot
04719872980322The QT ECG Disposable Electrode Strip is a self-adhesive, single use, one-piece integrated ECG e
04719872980315The QT ECG Disposable Electrode Strip is a self-adhesive, single use, one-piece integrated ECG e
04719872980308The QT ECG Disposable Electrode Strip is a self-adhesive, single use, one-piece integrated ECG e
04719872980483The electrode is disposable with a sensing element and is designed for ECG. It is applied to the
04719872980476The electrode is disposable with a sensing element and is designed for ECG. It is applied to the
04719872980469The electrode is disposable with a sensing element and is designed for ECG. It is applied to the
04719872980452The electrode is disposable with a sensing element and is designed for ECG. It is applied to the
04719872980339PCA-A200 Electrode Cable is intended to be used with ECG devices. The Electrode Cable is used t
04719872980254PCA-C100 Patient Cable is intended to be used with QT ECG device. The Patient Cable is used to
04719872980940PCA-C100BL Patient Cable is intended to be used with QT ECG device. The Patient Cable is used to
04719872981350PCA-A400 ECG Extension cable is used to extend and transmit ECG signals from patients for genera
04719872980933ECG Cable Converter Box is intended to be used with a QT ECG device. ECG Cable Converter Box is
04719872981466The QT ECG Disposable Electrode Strip is a self-adhesive, single-use, one-piece integrated ECG e
04719872981459The QT ECG Disposable Electrode Strip is a self-adhesive, single-use, one-piece integrated ECG e
04719872981442The QT ECG Disposable Electrode Strip is a self-adhesive, single use, one-piece integrated ECG e
04719872981435The QT ECG Disposable Electrode Strip is a self-adhesive, single-use, one-piece integrated ECG e
04719872981428The QT ECG Disposable Electrode Strip is a self-adhesive, single-use, one-piece integrated ECG e
04719872981411The QT ECG Disposable Electrode Strip is a self-adhesive, single-use, one-piece integrated ECG e
04719872981404The QT ECG Disposable Electrode Strip is a self-adhesive, single-use, one-piece integrated ECG e
04719872980896The QT ECG system is a hand-held, cordless 12-lead electrocardiograph (ECG) system with Bluetoot
04719872981510The QT ECG system is a hand-held, cordless 12-lead electrocardiograph (ECG) system with Bluetoot

Trademark Results [QT ECG]

Mark Image

Registration | Serial
Company
Trademark
Application Date
QT ECG
QT ECG
98242761 not registered Live/Pending
QT Medical, Inc.
2023-10-26
QT ECG
QT ECG
87518265 5326318 Live/Registered
QT Medical, Inc
2017-07-06
QT ECG
QT ECG
86776634 not registered Dead/Abandoned
QT Medical, Inc
2015-10-02

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