Powerheart®Pediatric Pads 2019199-003

GUDID 00812394020607

Pediatric defibrillation pads with two-year shelf life under GE part number

Cardiac Science Corporation

External defibrillator electrode, paediatric, single-use

• Primary Device ID: 00812394020607
• NIH Device Record Key: 575e7949-d48e-4919-afa0-1dba1fa36f23
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Powerheart®Pediatric Pads
• Version Model Number: 2019199-003
• Catalog Number: 2019199-003
• Company DUNS: 190713797
• Company Name: Cardiac Science Corporation
• 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: true
• 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: +1.262.953.3500
• Email: techsupport@cardiacscience.com
• Phone: +1.262.953.3500
• Email: techsupport@cardiacscience.com
• Phone: +1.262.953.3500
• Email: techsupport@cardiacscience.com
• Phone: +1.262.953.3500
• Email: techsupport@cardiacscience.com
• Phone: +1.262.953.3500
• Email: techsupport@cardiacscience.com
• Phone: +1.262.953.3500
• Email: techsupport@cardiacscience.com
• Phone: +1.262.953.3500
• Email: techsupport@cardiacscience.com
• Phone: +1.262.953.3500
• Email: techsupport@cardiacscience.com
• Phone: +1.262.953.3500
• Email: techsupport@cardiacscience.com
• Phone: +1.262.953.3500
• Email: techsupport@cardiacscience.com
• Phone: +1.262.953.3500
• Email: techsupport@cardiacscience.com
• Phone: +1.262.953.3500
• Email: techsupport@cardiacscience.com
• Phone: +1.262.953.3500
• Email: techsupport@cardiacscience.com
• Phone: +1.262.953.3500
• Email: techsupport@cardiacscience.com
• Phone: +1.262.953.3500
• Email: techsupport@cardiacscience.com
• Phone: +1.262.953.3500
• Email: techsupport@cardiacscience.com
• Phone: +1.262.953.3500
• Email: techsupport@cardiacscience.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 Degrees Celsius and 43 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 43 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 43 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 43 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 43 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 43 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 43 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 43 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 43 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 43 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 43 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 43 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 43 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 43 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 43 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 43 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 43 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 43 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 43 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 43 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 43 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 43 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 43 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 43 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 43 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 43 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 43 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 43 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 43 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 43 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 43 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 43 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 43 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 43 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00812394020607 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K022929

FDA Product Code

• MKJ: Automated External Defibrillators (Non-Wearable)

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-07-24

On-Brand Devices [Powerheart®Pediatric Pads]

• 00812394020607: Pediatric defibrillation pads with two-year shelf life under GE part number
• 00812394020256: Pediatric defibrillation pads with two-year shelf life