FDA.reportPublic FDA data

Flying-V cuff SMALL

Primary DI
09120073932075
Brand
Flying-V cuff SMALL
Company
CNSystems Medizintechnik GmbH
Model
G2.2
Catalog number
FVMA0051
Device description
Unit; Fingersensor for Task Force® Monitor (small); Luer
Published
2018-11-28
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DSBPlethysmograph, Impedance

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DSBPlethysmograph, ImpedanceCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K014063000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K014063000TASK FORCE MONITOR 3040Cnsystems Medizintechnik GmbH2002-02-07DSB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
09120073932075PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09120073932075091200739320759120073932075

GMDN Terms#

Term, Definition table
TermDefinition
Single-patient intensive/general healthcare physiologic monitoring systemAn assembly of electrically-powered devices designed for the continuous assessment of several vital physiologic parameters (e.g., ECG, blood pressure, heart rate, temperature, cardiac output, apnoea, and respiratory/anaesthetic gas concentrations) of one patient in intensive or general healthcare settings. It typically includes a central station monitor that receives, consolidates, and displays the information, and/or a bedside patient monitor; it often includes programmable alarms, portable radio transmitters, receivers, and antennas (telemetry systems) to allow monitoring during patient ambulation or transportation; it is not dedicated to neonatal use.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure70 KiloPascal106 KiloPascal
Handling Environment Humidity30 Percent (%) Relative Humidity85 Percent (%) Relative Humidity
Handling Environment Temperature10 Degrees Celsius40 Degrees Celsius
Storage Environment Atmospheric Pressure50 KiloPascal106 KiloPascal
Storage Environment Humidity20 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature0 Degrees Celsius40 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+4331672345633service@cnsystems.com

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

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