FDA.reportPublic FDA data

Cardiac, 10-Lead, IEC, Basic Monitoring Kit

Primary DI
08720938410383
Brand
Cardiac, 10-Lead, IEC, Basic Monitoring Kit
Company
Fysicon B.V.
Model
Cardiac, 10-Lead, IEC, Basic Monitoring Kit
Catalog number
01076150
Device description
This ECG trunk cable or Lead Wire is intended to be used with ECG (EKG) monitoring devices such as a QMAPP hemodynamic monitoring systems. This ECG Trunk cable or Lead wire is used to connect electrodes to a monitoring device for general monitoring and/or diagnostic evaluation by a health care professional. This ECG Trunk cable or Lead wire are reusable.
Published
2026-08-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
DSACable, Transducer And Electrode, Patient, (Including Connector)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DSACable, Transducer And Electrode, Patient, (Including Connector)Cardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K241766000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K241766000QMAPP® (Hemo, Hemo Lite, PCM, GO, Hybrid)Fysicon BV2025-08-27MWI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08720938410383PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08720938410383087209384103838720938410383

GMDN Terms#

Term, Definition table
TermDefinition
Multiple physiological parameter monitoring support kitA collection of noninvasive devices intended to be used in conjunction with a parent physiological parameter monitor for enabling measurement of multiple vital parameters [e.g., electrocardiogram (ECG), noninvasive blood pressure (NIBP), temperature]. It typically includes an inflatable blood pressure cuff, patient temperature probe, and electrical cables for connection to the monitor (e.g., for connecting an ECG lead to the monitor). This is a reusable device.

Regulatory Flags#

DUNS number
404866654
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
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
08720938410390Cardiac, 10-Lead, AHA, Basic Monitoring KitCardiac, 10-Lead, AHA, Basic Monitoring Kit010761512026-08-14
08720938410406IR, 5-Lead, IEC, Basic Monitoring KitIR, 5-Lead, IEC, Basic Monitoring Kit010761522026-08-14
08720938410413IR, 5-Lead, AHA, Basic Monitoring KitIR, 5-Lead, AHA, Basic Monitoring Kit010761532026-08-14
08720938410420ACIST FFR Connection KitACIST FFR Connection Kit010761542026-08-14
08720938410437Volcano (Philips) FFR Connection KitVolcano (Philips) FFR Connection Kit010761562026-08-14
08720938410444ABBOTT FFR Connection KitABBOTT FFR Connection Kit019761552026-08-14
08720938410451BOSTON FFR Connection KitBOSTON FFR Connection Kit010761572026-08-14
08720938410284QMAPPQMAPP Cardiac Output Inline temperature probe018020572026-06-26
08719689142124QMAPP QMAPP HEMO010761012026-05-19
08719689142131QMAPP QMAPP HEMO LT010761032026-05-19
08719689142162QMAPP QMAPP GO010761102026-05-19
08719689142179QMAPP QMAPP PCM010761002026-05-19
08719689142209QMAPP Lead set (10 pcs) IEC, Grabber, Radiolucent (4 Lim015670022026-05-19
08719689142216QMAPP QMAPP 10 Lead ECG trunck cable, IEC 165 cm015670312026-05-19
08719689142223QMAPP QMAPP 10 Lead ECG trunk cable, IEC 320 cm015670802026-05-19
08719689142247QMAPP QMAPP 5 Lead ECG trunk cable, IEC 165 CM015670562026-05-19
08719689142254QMAPP QMAPP 5 Lead ECG trunk cable, IEC 320 cm015670812026-05-19
08719689142261QMAPP 5 Lead (IEC) Radiopaque Lead wire set with grabber015670582026-05-19
08719689142322QMAPPQMAPP IBP connection cable BD, Argon - Merit DTX P015670222026-05-19
08719689142339QMAPPQMAPP IBP Connection cable - Namic, Angiodynamics 015670642026-05-19

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Primary DI, Brand, Company table
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00840416607185FOGG SYSTEM COMPANY, INC.Fogg System Company, Inc.DSA2026-08-17
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08720938410406IR, 5-Lead, IEC, Basic Monitoring KitFysicon B.V.DSA2026-08-14
08720938410413IR, 5-Lead, AHA, Basic Monitoring KitFysicon B.V.DSA2026-08-14
08720938410420ACIST FFR Connection KitFysicon B.V.DSA2026-08-14
08720938410437Volcano (Philips) FFR Connection KitFysicon B.V.DSA2026-08-14
08720938410444ABBOTT FFR Connection KitFysicon B.V.DSA2026-08-14
08720938410451BOSTON FFR Connection KitFysicon B.V.DSA2026-08-14
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