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 ID: 05700002223050
• NIH Device Record Key: 607646cd-7e5e-4254-bf75-8b127e57d188
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Acarix CADScor System
• Version Model Number: ACS-1401
• Catalog Number: ACS-1401 (1x, US-FDA)
• Company DUNS: 305132443
• Company Name: Acarix A/S
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 9999999999
• Email: xx@xx.xx
• Phone: 9999999999
• Email: xx@xx.xx
• Phone: 9999999999
• Email: xx@xx.xx
• Phone: 9999999999
• Email: xx@xx.xx
• Phone: 9999999999
• Email: xx@xx.xx
• Phone: 9999999999
• Email: xx@xx.xx
• Phone: 9999999999
• Email: xx@xx.xx
• Phone: 9999999999
• Email: xx@xx.xx
• Phone: 9999999999
• Email: xx@xx.xx
• Phone: 9999999999
• Email: xx@xx.xx
• Phone: 9999999999
• Email: xx@xx.xx
• Phone: 9999999999
• Email: xx@xx.xx
• Phone: 9999999999
• Email: xx@xx.xx
• Phone: 9999999999
• Email: xx@xx.xx
• Phone: 9999999999
• Email: xx@xx.xx
• Phone: 9999999999
• Email: xx@xx.xx

Operating and Storage Conditions

• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Store at +10C to +40C; at RH >20-80%< RH non-condensing.
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 75 KiloPascal and 0 KiloPascal
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Store at +10C to +40C; at RH >20-80%< RH non-condensing.
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 75 KiloPascal and 0 KiloPascal
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Store at +10C to +40C; at RH >20-80%< RH non-condensing.
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 75 KiloPascal and 0 KiloPascal
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Store at +10C to +40C; at RH >20-80%< RH non-condensing.
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 75 KiloPascal and 0 KiloPascal
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Store at +10C to +40C; at RH >20-80%< RH non-condensing.
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 75 KiloPascal and 0 KiloPascal
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Store at +10C to +40C; at RH >20-80%< RH non-condensing.
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 75 KiloPascal and 0 KiloPascal
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Store at +10C to +40C; at RH >20-80%< RH non-condensing.
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 75 KiloPascal and 0 KiloPascal
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Store at +10C to +40C; at RH >20-80%< RH non-condensing.
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 75 KiloPascal and 0 KiloPascal
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Store at +10C to +40C; at RH >20-80%< RH non-condensing.
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 75 KiloPascal and 0 KiloPascal
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Store at +10C to +40C; at RH >20-80%< RH non-condensing.
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 75 KiloPascal and 0 KiloPascal
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Store at +10C to +40C; at RH >20-80%< RH non-condensing.
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 75 KiloPascal and 0 KiloPascal
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Store at +10C to +40C; at RH >20-80%< RH non-condensing.
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 75 KiloPascal and 0 KiloPascal
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Store at +10C to +40C; at RH >20-80%< RH non-condensing.
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 75 KiloPascal and 0 KiloPascal
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Store at +10C to +40C; at RH >20-80%< RH non-condensing.
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 75 KiloPascal and 0 KiloPascal
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Store at +10C to +40C; at RH >20-80%< RH non-condensing.
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 75 KiloPascal and 0 KiloPascal
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Store at +10C to +40C; at RH >20-80%< RH non-condensing.
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 75 KiloPascal and 0 KiloPascal

Device Identifiers

Device Issuing Agency	Device ID
GS1	05700002223050 [Primary]
GS1	05700002223067 [Package]; Package: Box of six [6 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• deNovo: DEN190047

FDA Product Code

• QMW: Coronary Artery Disease Risk Indicator From Acoustic Heart Signals

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-07-15
• Device Publish Date: 2021-07-07

Devices Manufactured by Acarix A/S

• 05700002223012 - Acarix CADScor Patch: 2021-07-15 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 System: 2021-07-15CADScor 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 System: 2021-07-15 CADScor System (ACS-1401), 1x system package. US-FDA version. The intended use of the CADScor System is to record heart sounds,