DEVICE: Isansys (05060488680274)
Device Identifier (DI) Information
Isansys
Lifetemp Sensor - V2 - Large
In Commercial Distribution
Lifetemp Sensor - V2 - Large
ISANSYS LIFECARE LIMITED
Lifetemp Sensor - V2 - Large
In Commercial Distribution
Lifetemp Sensor - V2 - Large
ISANSYS LIFECARE LIMITED
Continuous Clinical Thermometer
Device Characteristics
MR Unsafe | |
No | |
No | |
Yes | |
Yes | |
No | |
No | |
No | |
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? |
---|---|---|---|---|
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 |
---|---|
DRG | Transmitters And Receivers, Physiological Signal, Radiofrequency |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
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
6c8436ce-e161-472c-9d43-19a30bc3ee88
May 06, 2024
1
April 26, 2024
May 06, 2024
1
April 26, 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 |
---|---|---|---|---|---|
05060488680045 | 10 | 05060488680274 | In Commercial Distribution | Carton box |
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