HeRO ES

GUDID 00865536000210

MEDICAL PREDICTIVE SCIENCE CORPORATION

Neonatal/paediatric heart rate monitoring application software
Primary Device ID00865536000210
NIH Device Record Keya56eb61a-ad38-42db-934f-6bb845cd5966
Commercial Distribution StatusIn Commercial Distribution
Brand NameHeRO ES
Version Model Number3.1
Company DUNS164972296
Company NameMEDICAL PREDICTIVE SCIENCE CORPORATION
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone800-394-1625
Emailinfo@heroscore.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100865536000210 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DPSElectrocardiograph

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-14

Devices Manufactured by MEDICAL PREDICTIVE SCIENCE CORPORATION

00865536000210 - HeRO ES2018-07-06
00865536000210 - HeRO ES2018-07-06
00865536000227 - HeRO solo2018-07-06 A HeRO System for the private room
00865536000234 - HeRO duet2018-07-06 A standalone HeRO monitor for two infants
00865536000203 - HeRO symphony2018-03-29 Server based HeRO System

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