NPS3

GUDID 04057834024685

RAUMEDIC AG

Invasive-detection physiological monitor, battery-powered

• Primary Device ID: 04057834024685
• NIH Device Record Key: 0a819626-1bb1-42d6-9c85-a07acbb83e4f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NPS3
• Version Model Number: 091656-001
• Company DUNS: 332785323
• Company Name: RAUMEDIC AG
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +4992523590
• Email: hospitalcare@raumedic.com
• Phone: +4992523590
• Email: hospitalcare@raumedic.com
• Phone: +4992523590
• Email: hospitalcare@raumedic.com
• Phone: +4992523590
• Email: hospitalcare@raumedic.com
• Phone: +4992523590
• Email: hospitalcare@raumedic.com
• Phone: +4992523590
• Email: hospitalcare@raumedic.com
• Phone: +4992523590
• Email: hospitalcare@raumedic.com
• Phone: +4992523590
• Email: hospitalcare@raumedic.com
• Phone: +4992523590
• Email: hospitalcare@raumedic.com
• Phone: +4992523590
• Email: hospitalcare@raumedic.com
• Phone: +4992523590
• Email: hospitalcare@raumedic.com
• Phone: +4992523590
• Email: hospitalcare@raumedic.com
• Phone: +4992523590
• Email: hospitalcare@raumedic.com
• Phone: +4992523590
• Email: hospitalcare@raumedic.com
• Phone: +4992523590
• Email: hospitalcare@raumedic.com
• Phone: +4992523590
• Email: hospitalcare@raumedic.com
• Phone: +4992523590
• Email: hospitalcare@raumedic.com
• Phone: +4992523590
• Email: hospitalcare@raumedic.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	04057834024685 [Primary]

FDA Product Code

• GWM: Device, Monitoring, Intracranial Pressure

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-08-18

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• 04057834073393 - EASY logO: 2020-05-06
• 04057834073591 - MPR2 logO DATALOGGER: 2020-05-06
• 04057834073430 - Stand Holder DATALOGGER: 2019-06-07
• 04057834073454 - Table Stand DATALOGGER: 2019-03-07
• 04057834083439 - NPS2 Tempus Pro: 2018-12-14