FDA.reportPublic FDA data

TFC Adapter Plate

Primary DI
09120073932433
Brand
TFC Adapter Plate
Company
CNSystems Medizintechnik GmbH
Model
V1.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
09120073932433PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09120073932433091200739324339120073932433

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
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
09120073932952TFC Fingersensor 75 MEDIUMV4.x.y2023-10-18
09120073932969TFC Fingersensor 150 MEDIUMV4.x.y2023-10-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00885403529644Acumen IQ CuffBecton, Dickinson And CompanyDXN2026-07-31
00885403529651Acumen IQ CuffBecton, Dickinson And CompanyDXN2026-07-31
00885403533191Acumen IQ PlusBecton, Dickinson And CompanyDXN2026-07-31
00885403533207VitaWaveBecton, Dickinson And CompanyDXN2026-07-31
00885403529637Acumen IQBecton, Dickinson And CompanyDXN2026-07-29
00885403529668Acumen IQBecton, Dickinson And CompanyDXN2026-07-29
00885403529774ClearSight JrBecton, Dickinson And CompanyDXN2026-07-29
00885403529781ClearSightBecton, Dickinson And CompanyDXN2026-07-29
00885403529798ClearSightBecton, Dickinson And CompanyDXN2026-07-29
00885403529811ClearSightBecton, Dickinson And CompanyDXN2026-07-29
00885403529828VitaWaveBecton, Dickinson And CompanyDXN2026-07-29
00194346614035equateWAL-MART STORES, INC.DXN2026-07-28
06953825911683SAKER UltraShenzhen Urion Technology Co., LtdDXN2026-07-27
06953825911645N/AShenzhen Urion Technology Co., LtdDXN2026-07-24
06953825911652ANOVATORShenzhen Urion Technology Co., LtdDXN2026-07-24
06953825911669SPASTACISEShenzhen Urion Technology Co., LtdDXN2026-07-24
06932825306057CareSimpleGuangdong Transtek Medical Electronics Co.,LtdDXN2026-07-21
06932825306064CareSimpleGuangdong Transtek Medical Electronics Co.,LtdDXN2026-07-21
00073796318321WIDE-RANGE D-RING CUFFOmron Healthcare, Inc.DXN2026-07-20
00073796392437SMALL D-RING CUFFOmron Healthcare, Inc.DXN2026-07-20
00816042016516FORAFORA CARE INC.DXN2026-07-20
00898939002758FORAFORA CARE INC.DXN2026-07-20
06953825911515N/AShenzhen Urion Technology Co., LtdDXN2026-07-16
00850044118670iHealthiHealth Labs Inc.DXN2026-07-14
00850044118687iHealthiHealth Labs Inc.DXN2026-07-14
00850078377234iHealthiHealth Labs Inc.DXN2026-07-14