KARDIOSCREEN

Primary DI
00860003374917
Brand
KARDIOSCREEN
Company
IMEDRIX INC.
Model
1612A-CL
Device description
KardioScreen is a portable and mobile device intended to acquire a resting, diagnostic ECG using surface electrodes from adult patients and pediatric patients age 14-21 years. The device is intended to be used by doctors and/or trained healthcare professionals in a hospital, medical professional's facility, clinic, physician's office or any medical outreach center. The device can acquire, display, analyze and print either 6-lead or 12-lead electrocardiograms which can be exported for external use. The recorded ECG signals can help users to analyze and diagnose heart disease, but the device is not meant as a sole means of diagnosis.Senior Virtual HealthDevice DetailsKS-A00104,KS-A00110,KS-A00111,KS-A00112,KS-A00115,KS-A00117,KS-A00122,KS-A00131,KS-A00133,KS-A00136,KS-A00138,KS-A00139,KS-A00142,KS-A00145,KS-A00148,KS-A00149,KS-A00150KS Converter DetailsKS-CN-A00104,KS-CN-A00110,KS-CN-A00111,KS-CN-A00112,KS-CN-A00115,KS-CN-A00117,KS-CN-A00122,KS-CN-A00131,KS-CN-A00133,KS-CN-A00136,KS-CN-A00138,KS-CN-A00139,KS-CN-A00142,KS-CN-A00145,KS-CS-A00148,KS-CN-A00149,KS-CN-A00150Cable DetailsCMP220113-003 202201130002,CMP220113-003 202201130017,CMP220110-004 202201140008,CMP220110-004 202201140015,CMP220113-003 202201130026,CMP220113-003 202201130009,CMP220110-004 202201140023,CMP220113-003 202201130021,CMP220113-003 202201130022,CMP220113-003 202201130004,CMP220110-004 202201140018,CMP220113-003 202201130018,CMP220113-003 202201130010,CMP220110-004 202201140033,CMP220110-004 202201140027,CMP220113-003 202201130024,CMP220113-003 202201130001
Published
2024-01-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Product Codes#

Code, Name table
CodeName
DPSElectrocardiograph

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DPSElectrocardiographCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K191692000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K191692000KardioScreenImedrix Inc. (Formerly Piitech Inc.)2020-01-10DPS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860003374917PrimaryGS10
00860003374900Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860003374917008600033749178600033749170860003374917
00860003374900008600033749008600033749000860003374900

GMDN Terms#

Term, Definition table
TermDefinition
Electrocardiograph, professional, multichannelA device intended to be used by a healthcare professional in a clinical setting to acquire and process the electrical activity of the heart for digital display in the form of a graph, to assist a physician in assessing electrical cardiac physiology [electrocardiography (ECG)]. It is designed for recording the electrical signal from two or more configurations of electrodes (ECG-leads) at a time (multichannel) and may be intended for resting ECG and/or stress/exercise ECG. It will either include an integrated display or be designed to transmit ECG data to an off-the-shelf device for display; ECG electrodes may be included. Data interpretation and/or telemetry features might also be included.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
117027624
Device count
17
Kit
true
Serial number
true
Manufacturing date on label
true

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