DEVICE: EASY logO (04057834073393)

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Device Identifier (DI) Information

EASY logO
095264-002

RAUMEDIC AG
04057834073393
GS1
1
No description.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
Yes
No
No
No
No

GMDN

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Invasive-detection physiological monitor, line-powered A mains electricity (AC-powered) and/or battery-powered (with internal rechargeable batteries) device intended for continuous or intermittent measurement, display and/or recording of several invasively-detected physiological parameters [e.g., blood pressure, intracranial pressure (ICP), temperature, partial pressure of oxygen (pO2)]. It consists of a single unit intended to be used with an invasive device (e.g., arterial blood pressure catheter, intracerebral sensor catheter) which signals the monitor via connected cables. It may be a portable device that can be attached to the patient with a strap and may include alarms designed to alert clinical staff.
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FDA Product Code

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Product Code Product Code Name
GWM Device, Monitoring, Intracranial Pressure
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Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
Storage Environment Temperature: between -10 and 40 Degrees Celsius
Storage Environment Humidity: between 30 and 85 Percent (%) Relative Humidity
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Status

In Commercial Distribution
December 05, 2016

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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

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No
No
None
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Production Identifier(s) in UDI

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No
Yes
No
Yes
No CLOSE

Customer Contact

[?]
+4992523590
hospitalcare@raumedic.com
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