Saver EVO

Basic Information

• Brand Name: Saver EVO
• Primary DI: M727SAVEREVOH013
• Version / Model: 1.4.0
• Catalog Number: PAD-ACC-03
• Company Name: HEARTSINE TECHNOLOGIES LTD
• Labeler DUNS: 230479318
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-06-10
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: 03b8fabc-5c03-4df3-a722-52f4b0fc779f

Device Description

Saver EVO is a user friendly information management program to assist users to manage data from their defibrillation device. Saver EVO shall allow the user to download the data from a HeartSine device to a PC computer. Saver EVO™ data management software enables downloading, revie wing and printing ECG waveforms and event history data recorded in HeartSine samaritan PAD devices. Features of Saver EVO include:Comprehensive event documentation to facilitate physician oversight, Utstein style reporting and report export capabilities, User configuration setup and time synchronization, Simple point-and-click operation

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• 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: No
• 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	M727SAVEREVOH013	HIBCC

Customer Contacts

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