QHeart SENSOR

GUDID 04719872981633

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.

Qt Medical, Inc.

Electrocardiographic electrode, single-use

• Primary Device ID: 04719872981633
• NIH Device Record Key: f53be3e5-5155-4582-8a4f-2a30c52c9303
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: QHeart SENSOR
• Version Model Number: QTEOS120U
• Company DUNS: 078875059
• Company Name: Qt Medical, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	04719872981633 [Primary]

FDA Product Code

• DRX: Electrode, Electrocardiograph

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-07-16
• Device Publish Date: 2025-07-08

Devices Manufactured by Qt Medical, Inc.

• 04719872981541 - QT ECG: 2025-07-16 A reusable ECG patient cable is used to transmit cardiac electrical signals (ECG) from electrodes, which are affixed to the pati
• 04719872981558 - QT ECG: 2025-07-16 A reusable ECG patient cable is used to transmit cardiac electrical signals (ECG) from electrodes, which are affixed to the pati
• 04719872981565 - QT ECG: 2025-07-16 A reusable ECG patient cable is used to transmit cardiac electrical signals (ECG) from electrodes, which are affixed to the pati
• 04719872981572 - QT ECG: 2025-07-16 A reusable ECG patient cable is used to transmit cardiac electrical signals (ECG) from electrodes, which are affixed to the pati
• 04719872981589 - QT ECG: 2025-07-16 A reusable ECG patient cable is used to transmit cardiac electrical signals (ECG) from electrodes, which are affixed to the pati
• 04719872981633 - QHeart SENSOR: 2025-07-16The 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.
• 04719872981633 - QHeart SENSOR: 2025-07-16 The QT ECG Disposable Electrode Strip is a self-adhesive, single-use, one-piece integrated ECG electrode meant to use with QT EC
• 04719872981756 - QT ECG: 2025-05-20 The QT ECG system is a hand-held, cordless 12-lead electrocardiograph (ECG) system with Bluetooth connectivity.
• 04719872981534 - QT ECG: 2024-07-16 The QT ECG system is a hand-held, cordless 12-lead electrocardiograph (ECG) system with Bluetooth connectivity. The model is for