DEVICE: Acarix CADScor System (05700002223050)

Device Identifier (DI) Information

Acarix CADScor System
ACS-1401
In Commercial Distribution
ACS-1401 (1x, US-FDA)
Acarix A/S
05700002223050
GS1

1
305132443 *Terms of Use
CADScor System (ACS-1401), 1x system package. US-FDA version. The intended use of the CADScor System is to record heart sounds, murmurs and vibration for calculation of a patient specific score, indicating the risk of coronary stenosis, as an aid in cardiac analysis and diagnosis.
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Device Characteristics

MR Unsafe
No
No
No
Yes
No
No
No
No

GMDN

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
13017 Phonocardiograph
A device for recording heart sounds at the body surface through the heart's actions which cause vibrations that are transmitted through organs and tissue to the body surface. These are detected by microphones, processed in an electroacoustic transducer, and give sound characteristics in a phonocardiogram. This is used to assess the low frequency sounds (atrial and ventricular gallops), and high frequency sounds (mitral regurgitation and ventricular septal defect). Some also record subsonic frequencies (a few Hertz) considered as vibrations, typically recorded by an apexcardiograph. This method may also be integrated in other electrocardiograph (ECG) devices.
Obsolete false
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FDA Product Code

[?]
Product Code Product Code Name
QMW Coronary Artery Disease Risk Indicator From Acoustic Heart Signals
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
DEN190047 000
No CLOSE

Sterilization

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

[?]
Storage and Handling
Handling Environment Humidity: between 20 and 80 Percent (%) Relative Humidity
Special Storage Condition, Specify: Store at +10C to +40C; at RH >20-80%< RH non-condensing.
Handling Environment Temperature: between 10 and 40 Degrees Celsius
Handling Environment Atmospheric Pressure: more than 75 KiloPascal
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status

607646cd-7e5e-4254-bf75-8b127e57d188
July 15, 2021
1
July 07, 2021
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
05700002223067 6 05700002223050 In Commercial Distribution Box of six
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Secondary DI

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

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
No
Yes
No
No
No CLOSE

Customer Contact

[?]
9999999999
xx@xx.xx
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