HeRO symphony

GUDID 00865536000203

Server based HeRO System

MEDICAL PREDICTIVE SCIENCE CORPORATION

Neonatal/paediatric heart rate monitoring hardware

• Primary Device ID: 00865536000203
• NIH Device Record Key: fb375e79-f11e-4e79-a0a3-249aa2c2f0ac
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HeRO symphony
• Version Model Number: 3.1
• Company DUNS: 164972296
• Company Name: MEDICAL PREDICTIVE 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: true
• 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: 800-394-1625
• Email: info@heroscore.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00865536000203 [Primary]

FDA Product Code

• DPS: Electrocardiograph

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: 2016-09-29

Devices Manufactured by MEDICAL PREDICTIVE SCIENCE CORPORATION

• 00865536000210 - HeRO ES: 2018-07-06
• 00865536000227 - HeRO solo: 2018-07-06 A HeRO System for the private room
• 00865536000234 - HeRO duet: 2018-07-06 A standalone HeRO monitor for two infants
• 00865536000203 - HeRO symphony: 2018-03-29Server based HeRO System
• 00865536000203 - HeRO symphony: 2018-03-29 Server based HeRO System