NPS2 GE

GUDID 04057834099010

RAUMEDIC AG

Intracranial/compartmental-pressure monitor calibrator/cable
Primary Device ID04057834099010
NIH Device Record Key42710081-2a26-4a4c-8500-22d63a4db744
Commercial Distribution StatusIn Commercial Distribution
Brand NameNPS2 GE
Version Model Number093999-001
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
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 15 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity

Device Identifiers

Device Issuing AgencyDevice ID
GS104057834099010 [Primary]

FDA Product Code

GWMDevice, Monitoring, Intracranial Pressure

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-10-19
Device Publish Date2021-10-11

Devices Manufactured by RAUMEDIC AG

04057834099010 - NPS2 GE2021-10-19
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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