DEVICE: HeRO symphony (00086553600020)

Device Identifier (DI) Information

HeRO symphony
3.1
In Commercial Distribution

MEDICAL PREDICTIVE SCIENCE CORPORATION
00086553600020
GS1

1
164972296 *Terms of Use
Server based HeRO System
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
No
No
No
No
No

GMDN

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
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).
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.
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FDA Product Code

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Product Code Product Code Name
DPS Electrocardiograph
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
No CLOSE

Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
No storage/handling found
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

fb375e79-f11e-4e79-a0a3-249aa2c2f0ac
March 29, 2018
2
September 29, 2016
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

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No
No
None
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Production Identifier(s) in UDI

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Yes
No
No
Yes
No CLOSE

Customer Contact

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800-394-1625
info@heroscore.com
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