EventCare

Basic Information

• Brand Name: EventCare
• Primary DI: 00856298006190
• Version / Model: EventCare
• Catalog Number: 100792
• Company Name: SCOTTCARE CORPORATION, THE
• Labeler DUNS: 808204957
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-19
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: 97b7364f-d4ea-4ee4-8d0e-19dae3b62743

Device Description

The EventCare Event Monitoring System allows for the performance of traditional acoustic arrhythmia monitoring and the utilization of cellular event transmissions and monitoring. The system helps to maintain an accurate inventory of devices, patients’ records ECG events and reports. The system can also produce a wide array of administrative reports to help manage your monitoring operations. This program provides fast, accurate access to your patients’ events and Electrocardiographic recordings, regardless of time or location. EventCare allows you to receive live or recorded ECG transmissions over ordinary telephone lines, as well as cellular telephony networks, edit the ECG right on the computer screen, then print out a detailed, professional report.

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: Yes
• 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
DXH	Transmitters And Receivers, Electrocardiograph, Telephone	Cardiovascular	870.2920	2

GMDN Terms

Code	Name	Definition	Implantable	Status
44098	Cardiology information system application software	An application software program, routines, and/or algorithms intended to be used as or in an information system to electronically receive, collect, store, manage, assist in analysis of, display, output, and distribute data, within or between healthcare facilities, to support the administrative and clinical activities associated with the provision and utilization of cardiology services and facilities. It is typically supplied for installation into a dedicated information system for cardiology or existing mainframe or decentralized computers/networks.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00856298006190	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K061780	000