HeRO symphony

Basic Information

• Brand Name: HeRO symphony
• Primary DI: 00865536000203
• Version / Model: 3.1
• Company Name: MEDICAL PREDICTIVE SCIENCE CORPORATION
• Labeler DUNS: 164972296
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-29
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: fb375e79-f11e-4e79-a0a3-249aa2c2f0ac

Device Description

Server based HeRO System

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: 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
DPS	Electrocardiograph	Cardiovascular	870.2340	2

GMDN Terms

Code	Name	Definition	Implantable	Status
58702	Neonatal/paediatric heart rate monitoring hardware	A mains electricity (AC-powered) device designed to be connected between a physiological monitor and an off-the-shelf computer, containing dedicated application software, and intended to function as a data acquisition node for real-time sampling of neonatal/paediatric patient electrocardiogram (ECG) waveforms for communication to the software for analysis of variations in heart rate. It typically consists of a microprocessor, random access memory (RAM), and analogue-to-digital sampling card, and is typically used in the neonatal or paediatric intensive care unit (ICU).	No	Active
58703	Neonatal/paediatric heart rate monitoring application software	An application software program intended to be installed in an off-the-shelf computer to acquire, record, measure and analyse an electrocardiogram (ECG) signal or heart rate data from a physiological monitor. It typically detects variations in heart rate [e.g., decelerations, reduced baseline heart rate variability (HRV)] in real-time, and is typically used in the neonatal or paediatric intensive care unit (ICU). This device is 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	00865536000203	GS1

Customer Contacts

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