Heart Sync Sterile Adult Radio Transparent Multi Function Electrodes Sterile-C100

GUDID 10868866000032

The Heart Sync Sterile Adult 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 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). Compatible with "Anderson" adapted models of monophasic and bi-phasic defibrillators.

HEART SYNC INC

External defibrillator electrode pad

• Primary Device ID: 10868866000032
• NIH Device Record Key: 39576116-aa4e-4d00-a6bc-57bcffce52c3
• Commercial Distribution Discontinuation: 2016-09-30
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Heart Sync Sterile Adult Radio Transparent Multi Function Electrodes
• Version Model Number: Sterile-C100
• Catalog Number: Sterile-C100
• 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	00868866000035 [Primary]
GS1	10868866000032 [Package]; Contains: 00868866000035; Package: Box [10 Units]; Discontinued: 2016-09-30; Not in Commercial Distribution

FDA Product Code

• MKJ: Automated External Defibrillators (Non-Wearable)

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2014-09-16

On-Brand Devices [Heart Sync Sterile Adult Radio Transparent Multi Function Electrodes]

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