Heartsync by Vermed 6600063H

GUDID 50009336009614

Defibrillator Electrodes

GRAPHIC CONTROLS ACQUISITION CORP

External defibrillator electrode pad

• Primary Device ID: 50009336009614
• NIH Device Record Key: bebcd7ae-1a96-45b6-9b1d-e464330830cb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Heartsync by Vermed
• Version Model Number: PED-100
• Catalog Number: 6600063H
• 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
• Phone: 800-669-6905
• Email: info@vermed.com

Operating and Storage Conditions

• 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
• 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	00009336009619 [Primary]
GS1	50009336009614 [Package]; Contains: 00009336009619; Package: [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K080421

FDA Product Code

• LDD: Dc-Defibrillator, Low-Energy, (Including Paddles)

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: 2019-10-25
• Device Publish Date: 2019-10-17

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