FDA.reportPublic FDA data

BA-HFVI-V1

Primary DI
03760232460184
Brand
BA-HFVI-V1
Company
MDOLORIS MEDICAL SYSTEMS
Model
V1
Device description
The acquisiton box BA-HFVI-V1 is to be used with the MDoloris HVFI Monitor (UDI number : 03760232460177)
Published
2019-01-10
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe

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
03760232460184PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03760232460184037602324601843760232460184

GMDN Terms#

Term, Definition table
TermDefinition
Electrocardiograph, professional, single-channelA 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 only one configuration of electrodes (ECG-leads) at a time (single-channel). 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 data telemetry features might also be included.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
262207287
Device count
1
Premarket exempt
true
Combination product
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03760232460283HFVI-SC-V112019-01-10
03760232460177HFVi monitorV1 2016-12-21
03760232460245HFVI SENSOR V1V12019-01-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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