Acarix CADScor Patch

Basic Information

• Brand Name: Acarix CADScor Patch
• Primary DI: 05700002223029
• Version / Model: ACP-1401
• Catalog Number: ACP-1401 (20x)
• Company Name: Acarix A/S
• Labeler DUNS: 305132443
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 20
• Record Status: Published
• Publish Date: 2021-07-07
• Public Version: 1
• Public Version Date: 2021-07-15
• Public Version Status: New
• Public Device Record Key: 465f2081-31c7-406c-81fb-36f333081857

Device Description

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.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Unsafe
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
QMW	Coronary Artery Disease Risk Indicator From Acoustic Heart Signals	Cardiovascular	870.1420	2

GMDN Terms

Code	Name	Definition	Implantable	Status
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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	05700002223012	GS1
Primary	05700002223029	GS1
Package	05700002223036	GS1	Box of six	6	In Commercial Distribution

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
DEN190047	000

Storage Conditions

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