FDA.reportPublic FDA data

CardioXP

Primary DI
08809276940285
Brand
CardioXP
Company
Bionet CO,LTD
Model
CardioXP
Device description
ELECTROCARDIOGRAPH
Published
2021-07-15
Public version status
New
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K102767000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K102767000CARDIO XPBionet Co., Ltd.2011-06-03DPS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
18809276940282PackageGS14In Commercial Distribution
08809276940285PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1880927694028218809276940282
08809276940285088092769402858809276940285

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.

Regulatory Flags#

DUNS number
689708212
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
18809276943542CardioTouch3000CardioTouch30002021-07-15
18809276943559Cardio7Cardio72021-07-15
18809276943597FC700FC7002021-07-15
18809276943603FC1400FC14002021-07-15
18809276943641BM3/BM3 PlusBM3/BM3 Plus2021-07-15
18809276943726Spiro HandleSpiro Handle2021-07-15

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Primary DI, Brand, Company table
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00850086928022SENSINEL™ CARDIOPULMONARY MANAGEMENT (CPM) SYSTEM)Analog Devices, Inc.DPS2026-06-03
00850086928039SENSINEL™ CARDIOPULMONARY MANAGEMENT (CPM) SYSTEM)Analog Devices, Inc.DPS2026-06-03
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B3945700048100WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DPS2026-05-27
B3945700051020WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DPS2026-05-27
B3945700063010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DPS2026-05-27
B3945700064010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DPS2026-05-27
B3945700068020WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DPS2026-05-27
00810209880019CORE 500 Digital Stethoscope FIGS Earpiece - Rapid Response PinkEko Devices, Inc.DPS2026-04-03
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00195278620873MACGe Medical Systems Information Technologies, Inc.DPS2026-03-31
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