FDA.reportPublic FDA data

Smart ECG

Primary DI
08031527017334
Brand
Smart ECG
Company
MICROPORT CRM SRL
Model
K379
Catalog number
K379
Device description
MicroPort CRM Smart ECG
Published
2021-10-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
MRMDefibrillator, Implantable, Dual-Chamber

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MRMDefibrillator, Implantable, Dual-ChamberUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P980049137

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P980049137DEFENDER II MODEL 9201 IMPLANTABLE CARDIOVERTER DEFIBRILLATORMicroPort CRM USA, Inc.1999-09-15MRM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08031527017334PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08031527017334080315270173348031527017334

GMDN Terms#

Term, Definition table
TermDefinition
Electrocardiographic ambulatory recorderAn electrically-powered, noninvasive device designed to be worn by a patient during daily activities for 24-hour recording of the electrocardiographic signals of the heart, for the diagnosis of cardiac disorders (e.g., arrhythmias). The recorded measurements can be downloaded and analysed at a medical facility, typically using a computer with a dedicated software. Otherwise known as a Holter monitor, the device typically incorporates display and controls, and may include surface electrodes, lead wires and accessories intended for attachment/removal (e.g., wipes, adhesive remover).

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
438860859
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08031527013909ECG Cable4,5m2014-09-05
08031527013916ECG Cable3m2014-09-05
08031527015057SPIDERVIEW / SPIDERFLASH2 Leads / 3E2016-09-22
08031527015064SPIDERVIEWXYZ-HR / 7E2016-09-22
08031527015071SPIDERVIEW12 Leads / 10 E2016-09-22
08031527015088SPIDERVIEW2 Leads / 5 E2016-09-22
08031527015095SPIDERVIEW3 Leads XYZ / 7E2016-09-22
08031527016023SPIDERVIEW7 leads2016-09-22
08031527019789VegaTLD040UTLD040U2023-06-23
08031527019796VegaTLD041UTLD041U2023-06-23
08031527019802VegaTLD042UTLD042U2023-06-23
08031527019611CPR4B10031B100312023-06-26
08031527019819VegaRLK40URLK40U2023-06-26
08031527019826VegaRLK41URLK41U2023-06-26
08031527019833VegaRLK42URLK42U2023-06-26
08031527018997BlueSkyTPM020UTPM020U2023-06-23
08031527019000BlueSkyTPM021UTPM021U2023-06-23
08031527019017BlueSkyTPM024UTPM024U2023-06-23
08031527019024BlueSkyTPM025UTPM025U2023-06-23
08031527019932SmartViewSW001USW001U2023-06-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04035479182755Rivacor Sky DR-TBIOTRONIK SE & Co. KGMRM2026-04-20
04035479182823Acticor Sky DR-TBIOTRONIK SE & Co. KGMRM2026-04-20
04035479183004Rivacor Aura DR-TBIOTRONIK SE & Co. KGMRM2026-04-20
04035479183042Rivacor Rise DR-TBIOTRONIK SE & Co. KGMRM2026-04-20
08031527019611CPR4MICROPORT CRM SRLMRM2023-06-26
04035479156749Ilivia Neo 7 DR-T DF-1 ProMRIBIOTRONIK SE & Co. KGMRM2019-09-10
04035479156848Intica Neo 7 DR-T DF-1 ProMRIBIOTRONIK SE & Co. KGMRM2019-09-10
04035479156947Intica Neo 5 DR-T DF-1 ProMRIBIOTRONIK SE & Co. KGMRM2019-09-10
04035479156695Acticor 7 DR-T DF4 ProMRIBIOTRONIK SE & Co. KGMRM2019-03-18
04035479156794Rivacor 7 DR-T DF4 ProMRIBIOTRONIK SE & Co. KGMRM2019-03-18
04035479156893Rivacor 5 DR-T DF4 ProMRIBIOTRONIK SE & Co. KGMRM2019-03-18
04035479156992Rivacor 3 DR-T DF4 ProMRIBIOTRONIK SE & Co. KGMRM2019-03-18
04035479142094Ilivia 7 DR-T DF-1 ProMRIBIOTRONIK SE & Co. KGMRM2018-12-13
04035479142100Ilivia 7 DR-T DF4 ProMRIBIOTRONIK SE & Co. KGMRM2017-05-18
08031527015460PLATINIUMMICROPORT CRM SRLMRM2016-09-09
08031527015477PLATINIUMMICROPORT CRM SRLMRM2016-09-09
08031527015514PLATINIUMMICROPORT CRM SRLMRM2016-09-09
08031527015521PLATINIUMMICROPORT CRM SRLMRM2016-09-09
04035479128777Iperia 7 DR-T DF-1 ProMRIBIOTRONIK SE & Co. KGMRM2016-01-07
04035479128913Iperia 7 DR-T DF4 ProMRIBIOTRONIK SE & Co. KGMRM2016-01-07
08031527014654Remote Monitoring SystemMICROPORT CRM SRLMRM2015-10-05
08031527012827IntensiaMICROPORT CRM SRLMRM2015-02-20
08031527012834IntensiaMICROPORT CRM SRLMRM2015-02-20
04035479128784Iperia 7 DR-TBIOTRONIK SE & Co. KGMRM2015-02-18
04035479128807Itrevia 7 DR-T DF-1BIOTRONIK SE & Co. KGMRM2015-02-18
04035479128838Iperia 5 DR-TBIOTRONIK SE & Co. KGMRM2015-02-18
04035479128852Itrevia 5 DR-TBIOTRONIK SE & Co. KGMRM2015-02-18
04035479128883Iperia 5 DR-TBIOTRONIK SE & Co. KGMRM2015-02-18
04035479128906Itrevia 5 DR-TBIOTRONIK SE & Co. KGMRM2015-02-18
04035479128920Iperia 7 DR-TBIOTRONIK SE & Co. KGMRM2015-02-18