NPS3

GUDID 04057834024685

RAUMEDIC AG

Invasive-detection physiological monitor, battery-powered
Primary Device ID04057834024685
NIH Device Record Key0a819626-1bb1-42d6-9c85-a07acbb83e4f
Commercial Distribution StatusIn Commercial Distribution
Brand NameNPS3
Version Model Number091656-001
Company DUNS332785323
Company NameRAUMEDIC AG
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 Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+4992523590
Emailhospitalcare@raumedic.com
Phone+4992523590
Emailhospitalcare@raumedic.com
Phone+4992523590
Emailhospitalcare@raumedic.com
Phone+4992523590
Emailhospitalcare@raumedic.com
Phone+4992523590
Emailhospitalcare@raumedic.com
Phone+4992523590
Emailhospitalcare@raumedic.com
Phone+4992523590
Emailhospitalcare@raumedic.com
Phone+4992523590
Emailhospitalcare@raumedic.com
Phone+4992523590
Emailhospitalcare@raumedic.com
Phone+4992523590
Emailhospitalcare@raumedic.com
Phone+4992523590
Emailhospitalcare@raumedic.com
Phone+4992523590
Emailhospitalcare@raumedic.com
Phone+4992523590
Emailhospitalcare@raumedic.com
Phone+4992523590
Emailhospitalcare@raumedic.com
Phone+4992523590
Emailhospitalcare@raumedic.com
Phone+4992523590
Emailhospitalcare@raumedic.com
Phone+4992523590
Emailhospitalcare@raumedic.com
Phone+4992523590
Emailhospitalcare@raumedic.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity

Device Identifiers

Device Issuing AgencyDevice ID
GS104057834024685 [Primary]

FDA Product Code

GWMDevice, Monitoring, Intracranial Pressure

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2016-08-18

Devices Manufactured by RAUMEDIC AG

04057834099010 - NPS2 GE2021-10-19
04057834084054 - Wide range power adapter MPR 1/22021-05-18
04057834029215 - EASY logO2020-05-06
04057834073393 - EASY logO2020-05-06
04057834073591 - MPR2 logO DATALOGGER2020-05-06
04057834073430 - Stand Holder DATALOGGER2019-06-07
04057834073454 - Table Stand DATALOGGER2019-03-07
04057834083439 - NPS2 Tempus Pro2018-12-14

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