AED Manager, Powerheart G5

Basic Information

• Brand Name: AED Manager, Powerheart G5
• Primary DI: 00812394020188
• Version / Model: XAEDMGR01D
• Catalog Number: XAEDMGR01D
• Company Name: Cardiac Science Corporation
• Labeler DUNS: 190713797
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-04-29
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: e14b6a32-c148-4604-a67a-04d00c74358c

Device Description

Event Reporting and Administrative AED Configuration Software V.2.1.0.6 for Powerheart G5

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
MKJ	Automated External Defibrillators (Non-Wearable)	Cardiovascular	870.5310	3

GMDN Terms

Code	Name	Definition	Implantable	Status
41581	External defibrillator application software	An individual software application program or group of programs, routines or algorithms that add specific computer assisted display, processing and/or analysis capabilities to a defibrillator intended for external use on the thorax so that it may function according to its intended purpose. A basic set of applications programs and routines are included with the defibrillator and can be upgraded to correct programming errors or to add new system capabilities. Applications program packages are typically identified by a proprietary name and "version" or "upgrade" number.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00812394020188	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]