Acarix CADScor System ACS-1401 (1x, US-FDA)

GUDID 05700002223050

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.

Acarix A/S

Phonocardiograph Phonocardiograph Phonocardiograph Phonocardiograph Phonocardiograph Phonocardiograph Phonocardiograph Phonocardiograph Phonocardiograph Phonocardiograph Phonocardiograph Phonocardiograph Phonocardiograph Phonocardiograph Phonocardiograph Phonocardiograph
Primary Device ID05700002223050
NIH Device Record Key607646cd-7e5e-4254-bf75-8b127e57d188
Commercial Distribution StatusIn Commercial Distribution
Brand NameAcarix CADScor System
Version Model NumberACS-1401
Catalog NumberACS-1401 (1x, US-FDA)
Company DUNS305132443
Company NameAcarix A/S
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

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Operating and Storage Conditions

Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Store at +10C to +40C; at RH >20-80%< RH non-condensing.
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Atmospheric PressureBetween 75 KiloPascal and 0 KiloPascal
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Store at +10C to +40C; at RH >20-80%< RH non-condensing.
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Atmospheric PressureBetween 75 KiloPascal and 0 KiloPascal
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Store at +10C to +40C; at RH >20-80%< RH non-condensing.
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Atmospheric PressureBetween 75 KiloPascal and 0 KiloPascal
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Store at +10C to +40C; at RH >20-80%< RH non-condensing.
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Atmospheric PressureBetween 75 KiloPascal and 0 KiloPascal
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Store at +10C to +40C; at RH >20-80%< RH non-condensing.
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Atmospheric PressureBetween 75 KiloPascal and 0 KiloPascal
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Store at +10C to +40C; at RH >20-80%< RH non-condensing.
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Atmospheric PressureBetween 75 KiloPascal and 0 KiloPascal
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Store at +10C to +40C; at RH >20-80%< RH non-condensing.
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Atmospheric PressureBetween 75 KiloPascal and 0 KiloPascal
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Store at +10C to +40C; at RH >20-80%< RH non-condensing.
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Atmospheric PressureBetween 75 KiloPascal and 0 KiloPascal
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Store at +10C to +40C; at RH >20-80%< RH non-condensing.
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Atmospheric PressureBetween 75 KiloPascal and 0 KiloPascal
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Store at +10C to +40C; at RH >20-80%< RH non-condensing.
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Atmospheric PressureBetween 75 KiloPascal and 0 KiloPascal
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Store at +10C to +40C; at RH >20-80%< RH non-condensing.
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Atmospheric PressureBetween 75 KiloPascal and 0 KiloPascal
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Store at +10C to +40C; at RH >20-80%< RH non-condensing.
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Atmospheric PressureBetween 75 KiloPascal and 0 KiloPascal
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Store at +10C to +40C; at RH >20-80%< RH non-condensing.
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Atmospheric PressureBetween 75 KiloPascal and 0 KiloPascal
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Store at +10C to +40C; at RH >20-80%< RH non-condensing.
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Atmospheric PressureBetween 75 KiloPascal and 0 KiloPascal
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Store at +10C to +40C; at RH >20-80%< RH non-condensing.
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Atmospheric PressureBetween 75 KiloPascal and 0 KiloPascal
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Store at +10C to +40C; at RH >20-80%< RH non-condensing.
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Atmospheric PressureBetween 75 KiloPascal and 0 KiloPascal

Device Identifiers

Device Issuing AgencyDevice ID
GS105700002223050 [Primary]
GS105700002223067 [Package]
Package: Box of six [6 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

QMWCoronary Artery Disease Risk Indicator From Acoustic Heart Signals

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-07-15
Device Publish Date2021-07-07

Devices Manufactured by Acarix A/S

05700002223012 - Acarix CADScor Patch2021-07-15 Acarix CADScor Patch, 20x patch in box. The intended use of the CADScor System is to record heart sounds, murmurs and vibration
05700002223050 - Acarix CADScor System2021-07-15CADScor 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.
05700002223050 - Acarix CADScor System2021-07-15 CADScor System (ACS-1401), 1x system package. US-FDA version. The intended use of the CADScor System is to record heart sounds,

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