Acarix CADScor Patch ACP-1401 (20x)

GUDID 05700002223012

Acarix CADScor Patch, 20x patch in box. 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: 05700002223012
• NIH Device Record Key: 465f2081-31c7-406c-81fb-36f333081857
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Acarix CADScor Patch
• Version Model Number: ACP-1401
• Catalog Number: ACP-1401 (20x)
• Company DUNS: 305132443
• Company Name: Acarix A/S
• Device Count: 20
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• 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

• Special Storage Condition, Specify: Between 0 and 0 *Store at +10C to +40C; RH >20-80%< RH non-condensing.
• Special Storage Condition, Specify: Between 0 and 0 *Store at +10C to +40C; RH >20-80%< RH non-condensing.
• Special Storage Condition, Specify: Between 0 and 0 *Store at +10C to +40C; RH >20-80%< RH non-condensing.
• Special Storage Condition, Specify: Between 0 and 0 *Store at +10C to +40C; RH >20-80%< RH non-condensing.
• Special Storage Condition, Specify: Between 0 and 0 *Store at +10C to +40C; RH >20-80%< RH non-condensing.
• Special Storage Condition, Specify: Between 0 and 0 *Store at +10C to +40C; RH >20-80%< RH non-condensing.
• Special Storage Condition, Specify: Between 0 and 0 *Store at +10C to +40C; RH >20-80%< RH non-condensing.
• Special Storage Condition, Specify: Between 0 and 0 *Store at +10C to +40C; RH >20-80%< RH non-condensing.
• Special Storage Condition, Specify: Between 0 and 0 *Store at +10C to +40C; RH >20-80%< RH non-condensing.
• Special Storage Condition, Specify: Between 0 and 0 *Store at +10C to +40C; RH >20-80%< RH non-condensing.
• Special Storage Condition, Specify: Between 0 and 0 *Store at +10C to +40C; RH >20-80%< RH non-condensing.
• Special Storage Condition, Specify: Between 0 and 0 *Store at +10C to +40C; RH >20-80%< RH non-condensing.
• Special Storage Condition, Specify: Between 0 and 0 *Store at +10C to +40C; RH >20-80%< RH non-condensing.
• Special Storage Condition, Specify: Between 0 and 0 *Store at +10C to +40C; RH >20-80%< RH non-condensing.
• Special Storage Condition, Specify: Between 0 and 0 *Store at +10C to +40C; RH >20-80%< RH non-condensing.
• Special Storage Condition, Specify: Between 0 and 0 *Store at +10C to +40C; RH >20-80%< RH non-condensing.

Device Identifiers

Device Issuing Agency	Device ID
GS1	05700002223012 [Unit of Use]
GS1	05700002223029 [Primary]
GS1	05700002223036 [Package]; Contains: 05700002223029; 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: 2021-07-15Acarix CADScor Patch, 20x patch in box. 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.
• 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: 2021-07-15 CADScor System (ACS-1401), 1x system package. US-FDA version. The intended use of the CADScor System is to record heart sounds,