DEVICE: Isansys (05060488680175)
Device Identifier (DI) Information
Isansys
Lifeguard Server
In Commercial Distribution
Lifeguard Server
ISANSYS LIFECARE LIMITED
Lifeguard Server
In Commercial Distribution
Lifeguard Server
ISANSYS LIFECARE LIMITED
Lifeguard Server - Data Server & remote display
Device Characteristics
Labeling does not contain MRI Safety Information | |
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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? |
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64902 | Physiological measuring device wireless data capture/transfer unit |
A mobile electronic device/device assembly designed to be used by a healthcare professional (e.g., nurse, caregiver) to capture patient physiological parameters from wireless patient measuring devices (e.g., wireless pulse oximeter, wireless thermometer) during routine patient checks (e.g., as part of nursing rounds) and wirelessly send the information to the electronic health record. It is intended to capture and transfer patient identification and time/date with the physiological data; it will typically in addition allow for manual entry of data. It typically includes a display monitor, wireless receivers, and barcode reader.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
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DRG | Transmitters And Receivers, Physiological Signal, Radiofrequency |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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K172329 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
f6c06318-3d7f-4d4f-b73a-9944648c8149
May 03, 2024
1
April 25, 2024
May 03, 2024
1
April 25, 2024
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