DEVICE: 106 Microdialysis Pump (07332699000034)

Device Identifier (DI) Information

106 Microdialysis Pump
106
In Commercial Distribution
P000003
M DIALYSIS INC.
07332699000034
GS1

1
824632087 *Terms of Use
No description.
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Device Characteristics

MR Unsafe
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 pump An electromechanical device intended to be used to create positive and/or negative pressure to circulate perfusion fluid and interstitial fluid dialysate to and from a monitoring site in a tissue (e.g., brain, liver, muscle), as part of a system used to monitor local 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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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
No CLOSE

Sterilization

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

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Storage and Handling
No storage/handling found
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

9e148cb0-8b40-4b9c-9c10-84e86b555b4d
March 29, 2018
2
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)

[?]
No
Yes
07332699001031
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Production Identifier(s) in UDI

[?]
No
Yes
No
No
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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