Powerheart® Polarized Adult Defibrillation Pads 9660-001

GUDID 00812394020249

Polarized Defibrillation Pads(adult) with two-year shelf life

Cardiac Science Corporation

Multifunction cardiac electrode, adult

• Primary Device ID: 00812394020249
• NIH Device Record Key: 73bc1a9d-e65c-42bd-9b9d-d7ee6ba3471e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Powerheart® Polarized Adult Defibrillation Pads
• Version Model Number: 9660-001
• Catalog Number: 9660-001
• 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

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00812394020249 [Primary]

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: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2014-09-29

On-Brand Devices [Powerheart® Polarized Adult Defibrillation Pads]

• 00812394020928: Polarized Defibrillation Pads(adult) with two-year shelf life
• 00812394020584: Polarized Defibrillation Pads(adult) with two-year shelf life under GE part number
• 00812394020249: Polarized Defibrillation Pads(adult) with two-year shelf life