NEUROVENT-TEMP

GUDID 04057834027594

RAUMEDIC AG

Intracerebral sensor catheter
Primary Device ID04057834027594
NIH Device Record Keyc66158f4-b3fe-4e2b-ae11-8ea04405cae9
Commercial Distribution StatusIn Commercial Distribution
Brand NameNEUROVENT-TEMP
Version Model Number094278-002
Company DUNS332785323
Company NameRAUMEDIC AG
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone8886470070
Emailhospitalcare@raumedic.com
Phone8886470070
Emailhospitalcare@raumedic.com
Phone8886470070
Emailhospitalcare@raumedic.com
Phone8886470070
Emailhospitalcare@raumedic.com
Phone8886470070
Emailhospitalcare@raumedic.com
Phone8886470070
Emailhospitalcare@raumedic.com
Phone8886470070
Emailhospitalcare@raumedic.com
Phone8886470070
Emailhospitalcare@raumedic.com
Phone8886470070
Emailhospitalcare@raumedic.com
Phone8886470070
Emailhospitalcare@raumedic.com
Phone8886470070
Emailhospitalcare@raumedic.com
Phone8886470070
Emailhospitalcare@raumedic.com
Phone8886470070
Emailhospitalcare@raumedic.com
Phone8886470070
Emailhospitalcare@raumedic.com
Phone8886470070
Emailhospitalcare@raumedic.com
Phone8886470070
Emailhospitalcare@raumedic.com
Phone8886470070
Emailhospitalcare@raumedic.com
Phone8886470070
Emailhospitalcare@raumedic.com
Phone8886470070
Emailhospitalcare@raumedic.com
Phone8886470070
Emailhospitalcare@raumedic.com
Phone8886470070
Emailhospitalcare@raumedic.com
Phone8886470070
Emailhospitalcare@raumedic.com

Device Dimensions

Outer Diameter3.1 Millimeter
Outer Diameter3.1 Millimeter
Outer Diameter3.1 Millimeter
Outer Diameter3.1 Millimeter
Outer Diameter3.1 Millimeter
Outer Diameter3.1 Millimeter
Outer Diameter3.1 Millimeter
Outer Diameter3.1 Millimeter
Outer Diameter3.1 Millimeter
Outer Diameter3.1 Millimeter
Outer Diameter3.1 Millimeter
Outer Diameter3.1 Millimeter
Outer Diameter3.1 Millimeter
Outer Diameter3.1 Millimeter
Outer Diameter3.1 Millimeter
Outer Diameter3.1 Millimeter
Outer Diameter3.1 Millimeter
Outer Diameter3.1 Millimeter
Outer Diameter3.1 Millimeter
Outer Diameter3.1 Millimeter
Outer Diameter3.1 Millimeter
Outer Diameter3.1 Millimeter

Operating and Storage Conditions

Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity

Device Identifiers

Device Issuing AgencyDevice ID
GS104057834027594 [Primary]

FDA Product Code

GWMDevice, Monitoring, Intracranial Pressure

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

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

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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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