QT ECG

GUDID 04719872980254

PCA-C100 Patient Cable is intended to be used with QT ECG device. The Patient Cable is used to connect electrodes placed at appropriate sites on the patient to an ECG device for general diagnostic evaluation by healthcare professionals.

QT MEDICAL, INC.

Electrocardiographic lead set, reusable Electrocardiographic lead set, reusable Electrocardiographic lead set, reusable Electrocardiographic lead set, reusable Electrocardiographic lead set, reusable Electrocardiographic lead set, reusable Electrocardiographic lead set, reusable Electrocardiographic lead set, reusable Electrocardiographic lead set, reusable Electrocardiographic lead set, reusable Electrocardiographic lead set, reusable Electrocardiographic lead set, reusable Electrocardiographic lead set, reusable Electrocardiographic lead set, reusable Electrocardiographic lead set, reusable Electrocardiographic lead set, reusable Electrocardiographic lead set, reusable Electrocardiographic lead set, reusable Electrocardiographic lead set, reusable Electrocardiographic lead set, reusable Electrocardiographic lead set, reusable Electrocardiographic lead set, reusable Electrocardiographic lead set, reusable Electrocardiographic lead set, reusable Electrocardiographic lead set, reusable Electrocardiographic lead set, reusable Electrocardiographic lead set, reusable Electrocardiographic lead set, reusable Electrocardiographic lead set, reusable Electrocardiographic lead set, reusable Electrocardiographic lead set, reusable Electrocardiographic lead set, reusable Electrocardiographic lead set, reusable Electrocardiographic lead set, reusable Electrocardiographic lead set, reusable

• Primary Device ID: 04719872980254
• NIH Device Record Key: 6278640f-4dc6-4e60-a6e9-e3b2cab295af
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: QT ECG
• Version Model Number: PCA-C100
• Company DUNS: 078875059
• Company Name: QT MEDICAL, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1 909 323 0007
• Email: service@qtmedical.com
• Phone: +1 909 323 0007
• Email: service@qtmedical.com
• Phone: +1 909 323 0007
• Email: service@qtmedical.com
• Phone: +1 909 323 0007
• Email: service@qtmedical.com
• Phone: +1 909 323 0007
• Email: service@qtmedical.com
• Phone: +1 909 323 0007
• Email: service@qtmedical.com
• Phone: +1 909 323 0007
• Email: service@qtmedical.com
• Phone: +1 909 323 0007
• Email: service@qtmedical.com
• Phone: +1 909 323 0007
• Email: service@qtmedical.com
• Phone: +1 909 323 0007
• Email: service@qtmedical.com
• Phone: +1 909 323 0007
• Email: service@qtmedical.com
• Phone: +1 909 323 0007
• Email: service@qtmedical.com
• Phone: +1 909 323 0007
• Email: service@qtmedical.com
• Phone: +1 909 323 0007
• Email: service@qtmedical.com
• Phone: +1 909 323 0007
• Email: service@qtmedical.com
• Phone: +1 909 323 0007
• Email: service@qtmedical.com
• Phone: +1 909 323 0007
• Email: service@qtmedical.com
• Phone: +1 909 323 0007
• Email: service@qtmedical.com
• Phone: +1 909 323 0007
• Email: service@qtmedical.com
• Phone: +1 909 323 0007
• Email: service@qtmedical.com
• Phone: +1 909 323 0007
• Email: service@qtmedical.com
• Phone: +1 909 323 0007
• Email: service@qtmedical.com
• Phone: +1 909 323 0007
• Email: service@qtmedical.com
• Phone: +1 909 323 0007
• Email: service@qtmedical.com
• Phone: +1 909 323 0007
• Email: service@qtmedical.com
• Phone: +1 909 323 0007
• Email: service@qtmedical.com
• Phone: +1 909 323 0007
• Email: service@qtmedical.com
• Phone: +1 909 323 0007
• Email: service@qtmedical.com
• Phone: +1 909 323 0007
• Email: service@qtmedical.com
• Phone: +1 909 323 0007
• Email: service@qtmedical.com
• Phone: +1 909 323 0007
• Email: service@qtmedical.com
• Phone: +1 909 323 0007
• Email: service@qtmedical.com
• Phone: +1 909 323 0007
• Email: service@qtmedical.com
• Phone: +1 909 323 0007
• Email: service@qtmedical.com
• Phone: +1 909 323 0007
• Email: service@qtmedical.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	04719872980254 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K200722

FDA Product Code

• DSA: Cable, Transducer And Electrode, Patient, (Including Connector)

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: 2021-07-12
• Device Publish Date: 2021-07-02

On-Brand Devices [QT ECG]

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