FDA.reportPublic FDA data

CardeaScreen

Primary DI
00857553006009
Brand
CardeaScreen
Company
CARDIAC INSIGHT, INC.
Model
CS-2020-A
Catalog number
CS-2020-A
Device description
CardeaScreen is a portable ECG recorder designed for collection of resting (non-ambulatory) ECG data with software used for subsequent analysis of the patient's ECG data.
Published
2016-09-24
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DPSElectrocardiograph

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DPSElectrocardiographCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K123217000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K123217000CARDEASCREENCardea Associates, Inc.2013-02-05DPS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00857553006009PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00857553006009008575530060098575530060090857553006009

GMDN Terms#

Term, Definition table
TermDefinition
Electrocardiograph, professional, multichannelA device intended to be used by a healthcare professional in a clinical setting to record the electrical activity of the heart and display it in the form of a graph, to assist a physician in assessing electrical cardiac physiology [electrocardiography (ECG)]. It is designed to record the electrical signal from two or more configurations of electrodes (ECG-leads) at a time (multichannel). It may be intended for use while the patient is at rest (rest ECG) and/or during physical exercise (stress/exercise ECG), and may include a variety of additional features [e.g., interpretive software, data telemetry, display screen]; electrodes may be included.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
2065962060info@cardiacinsightinc.com

Regulatory Flags#

DUNS number
827419834
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00857553006016Cardea 20/20 ECGCS-2020-BCS-2020-B2023-08-24
20857553006072Stealth System S300M300-5M300-52017-03-29
00857553006092Stealth System S300C300/D300C300/D3002017-03-29
10857553006129Cardea SOLOC300/D300C300/D3002017-07-31
10857553006112Cardea SOLOM300-5M300-52017-07-31
00857553006122Cardea SOLOC300/D300C300/D3002017-07-31
00857553006139Cardea SOLOD300D3002019-08-21

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