FDA.reportPublic FDA data

TFC Fingersensor 75 MEDIUM

Primary DI
09120073932952
Brand
TFC Fingersensor 75 MEDIUM
Company
CNSystems Medizintechnik GmbH
Model
V4.x.y
Published
2023-10-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Product Codes#

Code, Name table
CodeName
DXNSystem, Measurement, Blood-Pressure, Non-Invasive

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DXNSystem, Measurement, Blood-Pressure, Non-InvasiveCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K223332000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K223332000Task Force CORECnsystems Medizintechnik GmbH2023-04-12DXN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
09120073932952PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09120073932952091200739329529120073932952

GMDN Terms#

Term, Definition table
TermDefinition
Multiparameter physiologic analysis workstationA computerized unit intended to be used with a variety of noninvasive sensors (not included) for the non-continuous measurement of a variety of cardiovascular and pulmonary parameters [e.g., blood pressure, electrocardiography (ECG), SpO2, lung volume, airway resistance]; it might also be intended for additional physiologic analysis [e.g., electromyography (EMG), galvanic skin response (GSR)]. It includes sensor inputs, controls (e.g., touchscreen) and is intended to allow viewing, sharing and storage of the data; it is neither intended for continuous monitoring nor stress exercise monitoring.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
300526077
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
09120073933027CNAP® Monitor 500 HDV1.521-FHCN-155442024-07-10
09120073931948Set of electrodesV1.016162018-10-04
09120073931962Set of electrodesV1.016162018-10-04
09120073932273TFC NBP Cuff SMALL-2023-10-18
09120073932280TFC NBP Cuff MEDIUM-2023-10-18
09120073932297TFC NBP Cuff LARGE-2023-10-18
09120073932303TFC NBP Cuff X-LARGE-2023-10-18
09120073932327TFC CNAP Classic AdapterV1.x.y2023-10-18
09120073932334TFC Forearm ControllerV4.x.y2023-10-18
09120073932341TFC Forearm Controller ClampV1.x.y2023-10-18
09120073932365TFC Cable (2,5m)Vx2023-10-18
09120073932433TFC Adapter PlateV1.x.y2023-10-18
09120073932440TFC I/O CableV1.x.y2023-10-18
09120073932457Task Force® CORE ViewerV1.x.y2023-10-18
09120073932464TFC ArmslingV1.x.y2023-10-18
09120073932471TFC Forearm Controller Fixing StrapV3.x.y2023-10-18
09120073932716Task Force® Touch Workstation-2023-10-18
09120073932938TFC Fingersensor 75 SMALLV4.x.y2023-10-18
09120073932945TFC Fingersensor 150 SMALLV4.x.y2023-10-18
09120073932969TFC Fingersensor 150 MEDIUMV4.x.y2023-10-18

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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06953825911416N/AShenzhen Urion Technology Co., LtdDXN2026-07-13
00845717011556N/AShenzhen AOJ Medical Technology Co., LtdDXN2026-07-11
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06972040112842N/AShenzhen AOJ Medical Technology Co., LtdDXN2026-07-11
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06972040114365N/AShenzhen AOJ Medical Technology Co., LtdDXN2026-07-11
06972040117397N/AShenzhen AOJ Medical Technology Co., LtdDXN2026-07-11
MHC18602130N/AShenzhen AOJ Medical Technology Co., LtdDXN2026-07-11
06953825911294N/AShenzhen Urion Technology Co., LtdDXN2026-07-09
06953825911300N/AShenzhen Urion Technology Co., LtdDXN2026-07-09
06953825911317AlphamedShenzhen Urion Technology Co., LtdDXN2026-07-09
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06953825911393N/AShenzhen Urion Technology Co., LtdDXN2026-07-09
04250413403578Cuff ABPMpro without ECGSOMNOmedics AGDXN2026-07-07
04250413403585Cuff ABPMpro without ECGSOMNOmedics AGDXN2026-07-07
04250413406456Cuff ABPMpro for right armSOMNOmedics AGDXN2026-07-07
04250413406463Cuff ABPMpro for right armSOMNOmedics AGDXN2026-07-07
06927709404608JALIPShenzhen Jamr Technology Co., Ltd.DXN2026-07-06
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06973912940426IMDKShenzhen IMDK Medical Technology Co., LtdDXN2026-06-23
06926347900497POSTUREShenzhen Brav Electronic Technologies Co., Ltd.DXN2026-06-09
06953825911041ELERAShenzhen Urion Technology Co., LtdDXN2026-06-03
06953825911188sakerplusShenzhen Urion Technology Co., LtdDXN2026-06-03
06953825911218AlphamedShenzhen Urion Technology Co., LtdDXN2026-06-03