External inputs cable HEKA3141

GUDID 09120073931818

Unit; External inputs cable for Task Force® Monitor; 2,5m

CNSystems Medizintechnik GmbH

Single-patient intensive/general healthcare physiologic monitoring system
Primary Device ID09120073931818
NIH Device Record Keyc1a9e557-1928-4421-bbf9-9653ac51ece8
Commercial Distribution Discontinuation2019-01-16
Commercial Distribution StatusNot in Commercial Distribution
Brand NameExternal inputs cable
Version Model NumberX
Catalog NumberHEKA3141
Company DUNS300526077
Company NameCNSystems Medizintechnik GmbH
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+4331672345633
Emailservice@cnsystems.com
Phone+4331672345633
Emailservice@cnsystems.com
Phone+4331672345633
Emailservice@cnsystems.com
Phone+4331672345633
Emailservice@cnsystems.com
Phone+4331672345633
Emailservice@cnsystems.com
Phone+4331672345633
Emailservice@cnsystems.com
Phone+4331672345633
Emailservice@cnsystems.com
Phone+4331672345633
Emailservice@cnsystems.com
Phone+4331672345633
Emailservice@cnsystems.com
Phone+4331672345633
Emailservice@cnsystems.com
Phone+4331672345633
Emailservice@cnsystems.com
Phone+4331672345633
Emailservice@cnsystems.com
Phone+4331672345633
Emailservice@cnsystems.com
Phone+4331672345633
Emailservice@cnsystems.com
Phone+4331672345633
Emailservice@cnsystems.com
Phone+4331672345633
Emailservice@cnsystems.com
Phone+4331672345633
Emailservice@cnsystems.com
Phone+4331672345633
Emailservice@cnsystems.com
Phone+4331672345633
Emailservice@cnsystems.com

Operating and Storage Conditions

Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal

Device Identifiers

Device Issuing AgencyDevice ID
GS109120073931818 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DSBPlethysmograph, Impedance

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2020-02-06
Device Publish Date2018-11-28

Devices Manufactured by CNSystems Medizintechnik GmbH

09120073933027 - CNAP® Monitor 500 HD2024-07-18 Main Unit;
09120073931962 - Set of electrodes2023-12-18 Set of 4ECG electrodes, 3 ICG electrodes and one grounding pad
09120073932273 - TFC NBP Cuff SMALL2023-10-26
09120073932280 - TFC NBP Cuff MEDIUM2023-10-26
09120073932297 - TFC NBP Cuff LARGE2023-10-26
09120073932303 - TFC NBP Cuff X-LARGE2023-10-26
09120073932327 - TFC CNAP Classic Adapter2023-10-26
09120073932334 - TFC Forearm Controller2023-10-26

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.