Adult/Child, radiotransparent, defib electrodes with increased adhesive surface C300AC-ZOLL

GUDID 10854664006192

The Heart Sync Adult/Child Radio Transparent Multi Function Electrodes are indicated for use in external pacing, defibrillation and monitoring applications as a sterile, disposable device for single patient use only. The electrodes provide the conductive interface between the defibrillator and/or the external transcutaneous (noninvasive) cardiac pacemaker and the patient's skin. The electrode is intended for use on adult/child patients (>22lbs/10kg). When a patient requires defibrillation, cardioversion or external pacing, these electrodes will be applied to the patient and connected to the instrument. This device is intended for use on defibrillators whose output is classified as low power (360 joule maximum). Comparable with Zoll connector models of monophasic and bi-phasic defibrillators.

HEART SYNC INC

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• Primary Device ID: 10854664006192
• NIH Device Record Key: 89ff065b-9a63-4f41-84fa-b8802edbc65d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Adult/Child, radiotransparent, defib electrodes with increased adhesive surface
• Version Model Number: C300AC-ZOLL
• Catalog Number: C300AC-ZOLL
• Company DUNS: 041356039
• Company Name: HEART SYNC INC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 800.828.4681
• Email: CustomerService@heartsync.net
• Phone: 800.828.4681
• Email: CustomerService@heartsync.net
• Phone: 800.828.4681
• Email: CustomerService@heartsync.net
• Phone: 800.828.4681
• Email: CustomerService@heartsync.net
• Phone: 800.828.4681
• Email: CustomerService@heartsync.net
• Phone: 800.828.4681
• Email: CustomerService@heartsync.net
• Phone: 800.828.4681
• Email: CustomerService@heartsync.net
• Phone: 800.828.4681
• Email: CustomerService@heartsync.net
• Phone: 800.828.4681
• Email: CustomerService@heartsync.net
• Phone: 800.828.4681
• Email: CustomerService@heartsync.net
• Phone: 800.828.4681
• Email: CustomerService@heartsync.net
• Phone: 800.828.4681
• Email: CustomerService@heartsync.net
• Phone: 800.828.4681
• Email: CustomerService@heartsync.net
• Phone: 800.828.4681
• Email: CustomerService@heartsync.net
• Phone: 800.828.4681
• Email: CustomerService@heartsync.net
• Phone: 800.828.4681
• Email: CustomerService@heartsync.net
• Phone: 800.828.4681
• Email: CustomerService@heartsync.net
• Phone: 800.828.4681
• Email: CustomerService@heartsync.net

Operating and Storage Conditions

• Storage Environment Temperature: Between -20 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00854664006195 [Primary]
GS1	10854664006192 [Package]; Contains: 00854664006195; Package: [10 Units]; In Commercial Distribution

FDA Product Code

• MLN: Electrode, Electrodcardiograph, 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: 2018-03-29
• Device Publish Date: 2016-08-31

On-Brand Devices [Adult/Child, radiotransparent, defib electrodes with increased adhesive surface ]

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