AccessGUDID - DEVICE: Acarix CADScor System (05700002223050)

GUDID

Device Identifier (DI) Information

Brand Name: Acarix CADScor System
Version or Model: ACS-1401
Commercial Distribution Status: In Commercial Distribution
Catalog Number: ACS-1401 (1x, US-FDA)
Company Name: Acarix A/S

Primary DI Number: 05700002223050
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 305132443 *Terms of Use

Device Description: 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.

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

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

FDA Product Code

[?]

Product Code	Product Code Name
QMW	Coronary Artery Disease Risk Indicator From Acoustic Heart Signals

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
DEN190047	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

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

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 607646cd-7e5e-4254-bf75-8b127e57d188
Public Version Date: July 15, 2021
Public Version Number: 1
DI Record Publish Date: July 07, 2021