FDA.reportPublic FDA data

QMAPP

Primary DI
08719689142551
Brand
QMAPP
Company
Fysicon B.V.
Model
Disposable NiBP Cuff, Neonate (Navy Blue), 7-13 cm
Catalog number
01853010
Device description
The Reusable (durable) and Disposable Blood Pressure Cuffs are intended to be used with a non-invasive blood pressure measurement system, such as QMAPP, to determine blood pressure parameters on pediatric and adult patients. The Reusable (durable) and Disposable BP cuffs are a single bladder and shell construction, use to support ease of cleaning.
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
08719689142551PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08719689142551087196891425518719689142551

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
08720938410383Cardiac, 10-Lead, IEC, Basic Monitoring KitCardiac, 10-Lead, IEC, Basic Monitoring Kit010761502026-08-14
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00191506063191OPAL HDx™BOSTON SCIENTIFIC CORPORATIONDSA2026-10-28
04719872982296QT ECGQt Medical, Inc.DSA2026-10-28
04719872982302QT ECGQt Medical, Inc.DSA2026-10-28
04719872982418QT ECGQt Medical, Inc.DSA2026-10-28
06946725572924APKAPK Technology Co.,Ltd.DSA2026-10-26
00884838085299Dual IBP AdapterPhilips Medizin Systeme Böblingen GmbHDSA2026-10-21
G662ME361G1MaguireMaguire Enterprises, Inc.DSA2026-10-21
G662ME368G1MaguireMaguire Enterprises, Inc.DSA2026-10-21
00840416607406FOGG SYSTEM COMPANY, INC.Fogg System Company, Inc.DSA2026-10-19
00840416607413FOGG SYSTEM COMPANY, INC.Fogg System Company, Inc.DSA2026-10-19
00840416607420FOGG SYSTEM COMPANY, INC.Fogg System Company, Inc.DSA2026-10-19
00840416607437FOGG SYSTEM COMPANY, INC.Fogg System Company, Inc.DSA2026-10-19
00840416607444FOGG SYSTEM COMPANY, INC.Fogg System Company, Inc.DSA2026-10-19
G662ME590221F1MaguireMaguire Enterprises, Inc.DSA2026-10-19
G662ME590303G1MaguireMaguire Enterprises, Inc.DSA2026-10-16
00195278840202MACGe Medical Systems Information Technologies, Inc.DSA2026-10-13
06946725572139APKAPK Technology Co.,Ltd.DSA2026-10-13
042504134004853-channel ECG ElectrodeSOMNOmedics AGDSA2026-10-09
G662ME3311MaguireMaguire Enterprises, Inc.DSA2026-10-09
G662ME3381MaguireMaguire Enterprises, Inc.DSA2026-10-09
00840416607345FOGG SYSTEM COMPANY, INC.Fogg System Company, Inc.DSA2026-10-05
00840416607352FOGG SYSTEM COMPANY, INC.Fogg System Company, Inc.DSA2026-10-05
00840416607369FOGG SYSTEM COMPANY, INC.Fogg System Company, Inc.DSA2026-10-05
00840416607376FOGG SYSTEM COMPANY, INC.Fogg System Company, Inc.DSA2026-10-05
00840416607383FOGG SYSTEM COMPANY, INC.Fogg System Company, Inc.DSA2026-10-05
00840416607390FOGG SYSTEM COMPANY, INC.Fogg System Company, Inc.DSA2026-10-05
G662ME590015H1MaguireMaguire Enterprises, Inc.DSA2026-09-24
00191506063214OPAL HDx™BOSTON SCIENTIFIC CORPORATIONDSA2026-09-20
03700506301775INTEGRAL PROCESS Cables & LeadwiresNISSHA MEDICAL TECHNOLOGIES SASDSA2026-08-27
G662ME590032R1MaguireMaguire Enterprises, Inc.DSA2026-08-25