Acarix CADScor Patch

Primary DI
05700002223012
Brand
Acarix CADScor Patch
Company
Acarix A/S
Model
ACP-1401
Catalog number
ACP-1401 (20x)
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.
Published
2021-07-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
QMWCoronary Artery Disease Risk Indicator From Acoustic Heart Signals

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QMWCoronary Artery Disease Risk Indicator From Acoustic Heart SignalsCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
DEN190047000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
DEN190047000CADScor SystemAcarix A/S2020-11-24QMW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05700002223036PackageGS16In Commercial Distribution
05700002223029PrimaryGS10
05700002223012Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05700002223036057000022230365700002223036
05700002223029057000022230295700002223029
05700002223012057000022230125700002223012

GMDN Terms#

Term, Definition table
TermDefinition
PhonocardiographA 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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store at +10C to +40C; RH >20-80%< RH non-condensing.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
9999999999xx@xx.xx

Regulatory Flags#

DUNS number
305132443
Device count
20
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05700002223029Acarix CADScor PatchACP-1401ACP-1401 (20x)2021-07-07
05700002223050Acarix CADScor SystemACS-1401ACS-1401 (1x, US-FDA)2021-07-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05700002223029Acarix CADScor PatchAcarix A/SQMW2021-07-07
05700002223050Acarix CADScor SystemAcarix A/SQMW2021-07-07