Powerheart® MDLink 400621-045

GUDID 00812394020393

MDLink SW 10.15

Cardiac Science Corporation

External defibrillator application software

• Primary Device ID: 00812394020393
• NIH Device Record Key: fdba1c63-340d-4483-ae57-5a568a95fecf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Powerheart® MDLink
• Version Model Number: 400621-045
• Catalog Number: 400621-045
• 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: false
• Lot Batch: false
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00812394020393 [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: 2017-02-08

On-Brand Devices [Powerheart® MDLink]

• 00812394021321: MDLink SW 10.16
• 00812394020393: MDLink SW 10.15