FDA.reportPublic FDA data

ECG100+

Primary DI
08056732653610
Brand
ECG100+
Company
CARDIOLINE SPA
Model
ECG100+
Catalog number
80508095
Device description
12 lead high performance multichannel interpretative resting electrocardiograph which displays, acquires, prints and stores ECG tracings for adults and children 4,3 display and 100mm printer paper
Published
2017-04-11
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
K160840000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K160840000ECG100+, ECG200+Cardioline S.P.A2016-08-12DPS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08056732653610PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08056732653610080567326536108056732653610

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure70 KiloPascal106 KiloPascal
Handling Environment Humidity20 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Handling Environment Temperature10 Degrees Celsius40 Degrees Celsius
Storage Environment Atmospheric Pressure70 KiloPascal106 KiloPascal
Storage Environment Humidity20 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature0 Degrees Celsius40 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+393429026856b.palmieri@cardioline.it
+39046196821compliance@cardioline.com

Regulatory Flags#

DUNS number
339465174
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08056732654594HD+HD+810180272017-04-11
08056732654587touchECGtouchECG810195792017-04-12
08056732653450PATIENT CABLE SNAP 10 WIRES AHA FOR HD+63050165 rev. A630501652026-03-19
08056732652903touchECG WindowstouchECG Windows810195792025-06-10
08056732652422HD+12HD+12810183312025-02-26
08056732652712PATIENT CABLE SNAP 10 WIRES IEC FOR HD+ ORANGE63050104 rev. F630501042025-02-26
08056732652736PATIENT CABLE PLUG 10 WIRES AHA FOR HD+ ORANGE63050106 rev. F63050106 2025-02-26
08056732652491MidmarkMidmark Digital ECG1-100-15502023-12-05

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Primary DI, Brand, Company table
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00850086928039SENSINEL™ CARDIOPULMONARY MANAGEMENT (CPM) SYSTEM)Analog Devices, Inc.DPS2026-06-03
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