FDA.reportPublic FDA data

CardioCard

Primary DI
G466CUSB0
Brand
CardioCard
Company
NASIFF ASSOCIATES INC
Model
CUSB
Device description
CardioCard ECG, Stress system.
Published
2023-03-17
Public version status
New
Distribution status
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
G466CUSB0PrimaryHIBCC0

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.

Contacts#

Phone, Email table
PhoneEmail
3156762346nasales@nasiff.com

Regulatory Flags#

DUNS number
612902684
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
G466CUSBHOLT0CardioCard HolterCUSBHOLTERCC-HOLTER2023-04-04
G466CUSBNIBP0CardioCard NIBPCUSBNIBP2023-04-04

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Primary DI, Brand, Company table
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