DEVICE: ICUpilot Software eng (07332699000751)
Device Identifier (DI) Information
ICUpilot Software eng
English
In Commercial Distribution
8001027
M DIALYSIS INC.
English
In Commercial Distribution
8001027
M DIALYSIS INC.
No description.
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
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No | |
No | |
No | |
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No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
17223 | 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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Obsolete | false |
FDA Product Code
[?]Product Code | Product Code Name |
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OUG | Medical Device Data System |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Special Storage Condition, Specify: RT |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
2be6e0a6-d6cc-4e4f-99e9-58da236443c3
March 29, 2018
2
September 24, 2016
March 29, 2018
2
September 24, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
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No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
No Customer Contact currently defined