FDA.reportPublic FDA data

HD+

Primary DI
08056732654594
Brand
HD+
Company
CARDIOLINE SPA
Model
HD+
Catalog number
81018027
Device description
Digital portable acquisition device which can acquire the electrocardiographic signal of 12 standard leads. Connected with a receiver via Bluetooth, sends the data to the host.
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
DRGTransmitters And Receivers, Physiological Signal, Radiofrequency

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DRGTransmitters And Receivers, Physiological Signal, RadiofrequencyCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K150289000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K150289000CARDIOLINE HD+Cardioline S.P.A2015-08-27DRG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08056732654594PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08056732654594080567326545948056732654594

GMDN Terms#

Term, Definition table
TermDefinition
Multichannel electrocardiograph, signal-averagingAn instrument designed to measure electrical potentials on the body surface to generate a record of the electrical currents associated with heart muscle activity [i.e., an electrocardiogram (ECG)] for the assessment of cardiac physiology. It records electrical signals from two or more multiple electrode sets (leads) simultaneously to simplify and facilitate interpretation of the record by enabling the comparison of multiple-lead recording of the same heartbeat. It is noninterpretive and reduces signal noise level by performing an average of multiple cycles of the signal; it may be used to detect late potentials for the identification of patients prone to ventricular tachycardia.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure70 KiloPascal106 KiloPascal
Handling Environment Humidity25 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Handling Environment Temperature0 Degrees Celsius40 Degrees Celsius
Storage Environment Atmospheric Pressure70 KiloPascal106 KiloPascal
Storage Environment Humidity25 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
08056732653610ECG100+ ECG100+805080952017-04-11
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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04719875011023EZYPRO ECG RecorderSIGKNOW BIOMEDICAL CO., LTD.DRG2026-06-01
04719875011030EZYPRO ECG RecorderSIGKNOW BIOMEDICAL CO., LTD.DRG2026-06-01
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00198953024096Portrait CVAXBGe Medical Systems Information Technologies, Inc.DRG2025-12-10
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