QT ECG

Basic Information

• Brand Name: QT ECG
• Primary DI: 04719872980414
• Version / Model: QTERD100
• Company Name: Qt Medical, Inc.
• Labeler DUNS: 078875059
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-09-21
• Public Version: 4
• Public Version Date: 2023-04-21
• Public Version Status: Update
• Public Device Record Key: d4e06a29-8084-473f-a3f9-4ece56c69e27

Device Description

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

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: Yes
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Unsafe
• Direct Marking Exempt: Yes
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
DXH	Transmitters And Receivers, Electrocardiograph, Telephone	Cardiovascular	870.2920	2

GMDN Terms

Code	Name	Definition	Implantable	Status
62641	Electrocardiograph, home-use	A device intended to be used by a layperson in the home to acquire and process the electrical activity of the heart for digital display in the form of a graph, to assist a physician in assessing electrical cardiac physiology [electrocardiography (ECG)]. It may be available with a variety of features [e.g., single-channel, multichannel, interpretive software, data telemetry]; electrodes may be included.	No	Active
16231	Electrocardiograph, professional, multichannel	A device intended to be used by a healthcare professional in a clinical setting to acquire and process the electrical activity of the heart for digital display in the form of a graph, to assist a physician in assessing electrical cardiac physiology [electrocardiography (ECG)]. It is designed for recording the electrical signal from two or more configurations of electrodes (ECG-leads) at a time (multichannel) and may be intended for resting ECG and/or stress/exercise ECG. It will either include an integrated display or be designed to transmit ECG data to an off-the-shelf device for display; ECG electrodes may be included. Data interpretation and/or telemetry features might also be included.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04719872980414	GS1
Package	04719872980698	GS1		1	In Commercial Distribution
Package	04719872980742	GS1		1	In Commercial Distribution

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K180157	000

Device Sizes

Type	Value	Unit	Text
Height	18.6	Millimeter
Width	68.02	Millimeter
Depth	72	Millimeter

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: -25 – 70 Degrees Celsius
• Type: Storage Environment Humidity
• Temperature Range: 10 – 93 Percent (%) Relative Humidity
• Type: Storage Environment Atmospheric Pressure
• Temperature Range: 70 – 106 KiloPascal