FDA.reportPublic FDA data

QMAPP

Primary DI
08719689142209
Brand
QMAPP
Company
Fysicon B.V.
Model
Lead set (10 pcs) IEC, Grabber, Radiolucent (4 Lim
Catalog number
01567002
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
2026-05-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
08719689142209PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08719689142209087196891422098719689142209

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
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08719689142124QMAPP QMAPP HEMO010761012026-05-19
08719689142131QMAPP QMAPP HEMO LT010761032026-05-19
08719689142162QMAPP QMAPP GO010761102026-05-19
08719689142179QMAPP QMAPP PCM010761002026-05-19
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
08719689142346QMAPPQMAPP IBP Connection cable - Namic, Angiodynamics 015670782026-05-19
08719689142353QMAPPQMAPP IBP Connection cable - Abbott (320 cm)015670452026-05-19
08719689142360QMAPPQMAPP IBP Connection Cable - Merit Meritrans (320 018020302026-05-19
08719689142377QMAPPQMAPP IBP Connection cable - Utah, ADI (320 cm)018020322026-05-19
08719689142384QMAPPQMAPP IBP Connection cable - Medex Logical (320 cm018020342026-05-19
08719689142391QMAPPQMAPP IBP Connection Cable - Edwards, Baxter (320 015670712026-05-19
08719689142407QMAPPQMAPP Dual 'Y' - IBP connection cable015670342026-05-19
08719689142414QMAPPQMAPP SpO2 connection cable 300cm015670832026-05-19
08719689142469QMAPPReusable NiBP Cuff, Infant (Orange), 8-13 cm018530012026-05-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08719689142216QMAPP Fysicon B.V.DSA2026-05-19
08719689142223QMAPP Fysicon B.V.DSA2026-05-19
08719689142247QMAPP Fysicon B.V.DSA2026-05-19
08719689142254QMAPP Fysicon B.V.DSA2026-05-19
08719689142261QMAPP Fysicon B.V.DSA2026-05-19
08719689142322QMAPPFysicon B.V.DSA2026-05-19
08719689142339QMAPPFysicon B.V.DSA2026-05-19
08719689142346QMAPPFysicon B.V.DSA2026-05-19
08719689142353QMAPPFysicon B.V.DSA2026-05-19
08719689142360QMAPPFysicon B.V.DSA2026-05-19
08719689142377QMAPPFysicon B.V.DSA2026-05-19
08719689142384QMAPPFysicon B.V.DSA2026-05-19
08719689142391QMAPPFysicon B.V.DSA2026-05-19
08719689142407QMAPPFysicon B.V.DSA2026-05-19
08719689142414QMAPPFysicon B.V.DSA2026-05-19
08719689142469QMAPPFysicon B.V.DSA2026-05-19
08719689142476QMAPPFysicon B.V.DSA2026-05-19
08719689142483QMAPPFysicon B.V.DSA2026-05-19
08719689142490QMAPPFysicon B.V.DSA2026-05-19
08719689142506QMAPPFysicon B.V.DSA2026-05-19
08719689142513QMAPPFysicon B.V.DSA2026-05-19
08719689142520QMAPPFysicon B.V.DSA2026-05-19
08719689142537QMAPPFysicon B.V.DSA2026-05-19
08719689142544QMAPPFysicon B.V.DSA2026-05-19
08719689142551QMAPPFysicon B.V.DSA2026-05-19
08719689142568QMAPPFysicon B.V.DSA2026-05-19
08719689142575QMAPPFysicon B.V.DSA2026-05-19
08719689142582QMAPPFysicon B.V.DSA2026-05-19
08719689142599QMAPP Fysicon B.V.DSA2026-05-19
08719689142605QMAPP Fysicon B.V.DSA2026-05-19