DEVICE: ISCUSflex (07332699000607)

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Device Identifier (DI) Information

ISCUSflex
Clinical
8003295
M DIALYSIS INC.
07332699000607
GS1
1
No description.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
No
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
Microdialysis system analyser An instrument that may use one of several analytical techniques (e.g., spectrophotometry) to determine and display the concentration of analytes (e.g., glucose, lactate, pyruvate) in an interstitial fluid dialysate sample, as part of an assembly of devices used to monitor local body-tissue chemistry for the early detection of metabolic imbalances and/or cell damage, typically after surgery or during a metabolic disorder.
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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
Handling Environment Atmospheric Pressure: between 500 and 1060 millibar
Handling Environment Humidity: between 10 and 70 Percent (%) Relative Humidity
Handling Environment Temperature: between 18 and 28 Degrees Celsius
Storage Environment Atmospheric Pressure: between 500 and 1060 millibar
Storage Environment Humidity: between 10 and 80 Percent (%) Relative Humidity
Storage Environment Temperature: between 0 and 50 Degrees Celsius
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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
September 24, 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
Yes
07332699000744
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Production Identifier(s) in UDI

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No
Yes
No
No
No CLOSE

Customer Contact

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No Customer Contact currently defined
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