DEVICE: ICUpilot Software eng (07332699000751)

Device Identifier (DI) Information

ICUpilot Software eng
English
In Commercial Distribution
8001027
M DIALYSIS INC.
07332699000751
GS1

1
824632087 *Terms of Use
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
Bedside information system A dedicated assembly of devices designed to electronically receive, collect, store, manage, assist in analysis of, display, output, and distribute data, within or between healthcare facilities, to support the provision and utilization of administrative and clinical information at the patient's bedside. The system will typically provide healthcare staff with the ability to access and submit electronic patient data. It consists of dedicated combined hardware (e.g., computers, terminals, network components) and software (typically embedded).
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FDA Product Code

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Product Code Product Code Name
OUG Medical Device Data System
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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
Special Storage Condition, Specify: RT
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

2be6e0a6-d6cc-4e4f-99e9-58da236443c3
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)

[?]
Yes
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
No
No
No CLOSE

Customer Contact

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No Customer Contact currently defined
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