FDA.reportPublic FDA data

CardioTouch3000

Primary DI
18809276943542
Brand
CardioTouch3000
Company
Bionet CO,LTD
Model
CardioTouch3000
Device description
System, ecg analysis
Published
2021-07-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
false
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
DPSElectrocardiograph

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DPSElectrocardiographCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K023034000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K023034000CARDIOTOUCH-3000Bionet Company, Ltd.2002-11-14LOS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
18809276943542PackageGS14In Commercial Distribution
08809276943545PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1880927694354218809276943542
08809276943545088092769435458809276943545

GMDN Terms#

Term, Definition table
TermDefinition
ST-segment electrocardiographic monitorA mains electricity (AC-powered) bedside device designed to continuously detect, measure, and display a patient's electrocardiogram (ECG), and provide analysis of the ECG's ST segment, through leads and sensors attached to the patient; it may also measure and display other physiological parameters. ST-segment analysis may facilitate ischemia detection. The device is typically equipped with audible and/or visual alarms that are triggered when the patient's parameters drop below or exceed pre-set limits.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
689708212
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08809276940285CardioXPCardioXP2021-07-15
08809276943958Cardio Q50, Cardio Q70Cardio Q502026-05-26
08809276943965Cardio Q50, Cardio Q70Cardio Q702026-05-26
08809276943972Cardio P1Cardio P12026-05-26
08809276944269Cardio Q50, Cardio Q70CardioExpress 40122026-05-26
08809276944276Cardio Q50, Cardio Q70CardioExpress 50122026-05-26
08809276943552Cardio7Cardio72021-07-15
08809276943729Spiro HandleSpiro Handle2021-07-15
08809276943538CardioCare2000CardioCare20002021-07-15
08809276943545CardioTouch3000CardioTouch30002021-07-15
08809276943590FC700FC7002021-07-15
08809276943606FC1400FC14002021-07-15
08809276943644BM3/BM3 PlusBM3/BM3 Plus2021-07-15
18809276940282CardioXPCardioXP2021-07-15
18809276943535CardioCare2000CardioCare20002021-07-15
18809276943559Cardio7Cardio72021-07-15
18809276943597FC700FC7002021-07-15
18809276943603FC1400FC14002021-07-15
18809276943641BM3/BM3 PlusBM3/BM3 Plus2021-07-15
18809276943726Spiro HandleSpiro Handle2021-07-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00195278949752TruSignal SpO2 MM 3.0MGE Healthcare Finland OyDPS2026-10-04
00195278949769TruSignal SpO2 MM 1.8MGE Healthcare Finland OyDPS2026-10-04
00198953002186Carescape Dock F0GE Healthcare Finland OyDPS2026-10-04
00198953009567Carescape ONEGE Healthcare Finland OyDPS2026-10-04
00810209880118CORE 500 Digital Stethoscope - Lilac ChestpieceEko Health, Inc.DPS2026-10-01
00810209880163CORE 500 Digital Stethoscope FIGS Earpiece - EspressoEko Health, Inc.DPS2026-10-01
00810209880170CORE 500 Digital Stethoscope FIGS Earpiece - Ruby RedEko Health, Inc.DPS2026-10-01
00810209880187CORE 500 Digital Stethoscope - Ember ChestpieceEko Health, Inc.DPS2026-10-01
06944413835153Telemetry MonitorEdan Instruments, Inc.DPS2026-08-26
06944413835214Telemetry MonitorEdan Instruments, Inc.DPS2026-08-26
00884838096738Cardiac WorkstationPhilips Medizin Systeme Böblingen GmbHDPS2026-08-18
00884838096745Cardiac WorkstationPhilips Medizin Systeme Böblingen GmbHDPS2026-08-18
06944413844919SE-1202 Series ElectrocardiographEdan Instruments, Inc.DPS2026-07-21
06944413847422SE-1202 Series ElectrocardiographEdan Instruments, Inc.DPS2026-07-21
00850048674028HeartBeam ECG SystemHeartBeam, Inc.DPS2026-07-16
00810209880057CORE 500 Digital Stethoscope - Navy Blue EarpieceEko Health, Inc.DPS2026-06-12
00810209880064CORE 500 Digital Stethoscope - Military Green EarpieceEko Health, Inc.DPS2026-06-12
00810209880071CORE 500 Digital Stethoscope - Navy Blue BundleEko Health, Inc.DPS2026-06-12
00810209880088CORE 500 Digital Stethoscope - Military Green BundleEko Health, Inc.DPS2026-06-12
00732094354959Welch Allyn, Inc.WELCH ALLYN, INC.DPS2026-06-09
00850086928008SENSINEL™ CPM BASE STATIONAnalog Devices, Inc.DPS2026-06-03
00850086928015SENSINEL™ CPM WEARABLEAnalog Devices, Inc.DPS2026-06-03
00850086928022SENSINEL™ CARDIOPULMONARY MANAGEMENT (CPM) SYSTEM)Analog Devices, Inc.DPS2026-06-03
00850086928039SENSINEL™ CARDIOPULMONARY MANAGEMENT (CPM) SYSTEM)Analog Devices, Inc.DPS2026-06-03
B3944060056010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DPS2026-05-27
B3944670047010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DPS2026-05-27
B3945000030010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DPS2026-05-27
B3945300046010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DPS2026-05-27