Heartsync by Vermed 6600264H

GUDID 50009336010092

Defib Electrode

GRAPHIC CONTROLS ACQUISITION CORP

External defibrillator electrode pad External defibrillator electrode pad External defibrillator electrode pad External defibrillator electrode pad External defibrillator electrode pad External defibrillator electrode pad External defibrillator electrode pad External defibrillator electrode pad External defibrillator electrode pad External defibrillator electrode pad Electrode conductive skin pad, single-use Electrode conductive skin pad, single-use Electrode conductive skin pad, single-use Electrode conductive skin pad, single-use Electrode conductive skin pad, single-use Electrode conductive skin pad, single-use Electrode conductive skin pad, single-use Electrode conductive skin pad, single-use Electrode conductive skin pad, single-use Electrode conductive skin pad, single-use Electrode conductive skin pad, single-use Electrode conductive skin pad, single-use Electrode conductive skin pad, single-use Electrode conductive skin pad, single-use Electrode conductive skin pad, single-use Electrode conductive skin pad, single-use Electrode conductive skin pad, single-use

• Primary Device ID: 50009336010092
• NIH Device Record Key: c230a0a8-92e0-44a3-b6bc-9cea757e0a4e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Heartsync by Vermed
• Version Model Number: T100AC-SCHILLER
• Catalog Number: 6600264H
• Company DUNS: 002111896
• Company Name: GRAPHIC CONTROLS ACQUISITION CORP
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 800-669-6905
• Email: info@vermed.com
• Phone: 800-669-6905
• Email: info@vermed.com
• Phone: 800-669-6905
• Email: info@vermed.com
• Phone: 800-669-6905
• Email: info@vermed.com
• Phone: 800-669-6905
• Email: info@vermed.com
• Phone: 800-669-6905
• Email: info@vermed.com
• Phone: 800-669-6905
• Email: info@vermed.com
• Phone: 800-669-6905
• Email: info@vermed.com
• Phone: 800-669-6905
• Email: info@vermed.com
• Phone: 800-669-6905
• Email: info@vermed.com
• Phone: 800-669-6905
• Email: info@vermed.com
• Phone: 800-669-6905
• Email: info@vermed.com
• Phone: 800-669-6905
• Email: info@vermed.com
• Phone: 800-669-6905
• Email: info@vermed.com
• Phone: 800-669-6905
• Email: info@vermed.com
• Phone: 800-669-6905
• Email: info@vermed.com
• Phone: 800-669-6905
• Email: info@vermed.com
• Phone: 800-669-6905
• Email: info@vermed.com
• Phone: 800-669-6905
• Email: info@vermed.com
• Phone: 800-669-6905
• Email: info@vermed.com
• Phone: 800-669-6905
• Email: info@vermed.com
• Phone: 800-669-6905
• Email: info@vermed.com
• Phone: 800-669-6905
• Email: info@vermed.com
• Phone: 800-669-6905
• Email: info@vermed.com
• Phone: 800-669-6905
• Email: info@vermed.com
• Phone: 800-669-6905
• Email: info@vermed.com
• Phone: 800-669-6905
• Email: info@vermed.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00009336010097 [Primary]
GS1	50009336010092 [Package]; Contains: 00009336010097; Package: [10 Units]; In Commercial Distribution

FDA Product Code

• MLN: Electrode, Electrocardiograph, Multi-Function

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2021-11-01
• Device Publish Date: 2020-11-06

On-Brand Devices [Heartsync by Vermed]

• 50009336009683: Debrillator electrode
• 50009336009676: Defibrillation electrode
• 50009336009669: DEFIB ELECTRODE
• 50009336009645: Defib Electrode
• 50009336009638: DEFIB ELECTRODE
• 50009336009621: Defib Electrode
• 50009336009614: Defibrillator Electrodes
• 50009336009607: DEFIB ELECTRODE
• 50009336009591: DEFIB ELECTRODE
• 50009336009584: DEFIB
• 50009336009577: DEFIB ELECTRODE
• 50009336009560: DEFIB ELECTRODE
• 50009336009553: DEFIB ELECTRODE
• 50009336009546: DEFIB ELECTRODE
• 50009336009539: DEFIB ELECTRODE
• 50009336009522: Defibrillation electrode
• 50009336009515: Defibrillation electrode
• 50009336009508: DEFIB ELECTRODES
• 50009336009492: Defib Electrode
• 50009336009485: DEFIB ELECTRODE
• 50009336009478: Defibrillator Electrode
• 50009336010092: Defib Electrode
• 50009336010085: DEFIB ELECTRODE