FDA.reportPublic FDA data

HeRO solo

Primary DI
00865536000227
Brand
HeRO solo
Company
MEDICAL PREDICTIVE SCIENCE CORPORATION
Model
3.1
Device description
A HeRO System for the private room
Published
2016-09-29
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
DPSElectrocardiograph

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DPSElectrocardiographCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K081473000
K180242000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K081473000HERO, VERSION 2.0Medical Predictive Science Corp.2008-06-27DPS
K180242000HeRO Symphony, HeRO ES, HeRO solo/duetMedical Predictive Science Corporation2018-02-28DPS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00865536000227PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00865536000227008655360002278655360002270865536000227

GMDN Terms#

Term, Definition table
TermDefinition
Neonatal/paediatric heart rate monitoring application softwareAn 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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
800-394-1625info@heroscore.com

Regulatory Flags#

DUNS number
164972296
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00865536000203HeRO symphony3.12016-09-29
00865536000210HeRO ES3.12016-09-14
00865536000234HeRO duet3.12016-09-29

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