DEVICE: Exergen Temporal Scanner (10834098000591)
Device Identifier (DI) Information
Exergen Temporal Scanner
TAT-5000S-USB-GE2
In Commercial Distribution
124227-AC-GE
EXERGEN CORPORATION
TAT-5000S-USB-GE2
In Commercial Distribution
124227-AC-GE
EXERGEN CORPORATION
TAT-5000S-USB-GE2, ART, DEG C
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
No | |
No | |
Yes | |
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? |
---|---|---|---|---|
17888 | Infrared patient thermometer, skin |
A hand-held, electrically-powered instrument designed to estimate the temperature of a site on the skin (e.g., axilla, forehead) by measurement of body infrared emissions at this particular point. It provides a method to determine temperature patterns or variations on the surface of the skin (e.g., due to differences in perfusion). This device may be used in the home. This is a reusable device.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
FLL | Thermometer, Electronic, Clinical |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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K011291 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Storage Environment Temperature: between -20 and 50 Degrees Celsius |
Storage Environment Temperature: between -4 and 122 Degrees Fahrenheit |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
3006a152-4e68-4766-9995-298f9d5e1ed2
October 12, 2023
2
April 11, 2023
October 12, 2023
2
April 11, 2023
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
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
[?]
617-923-9900
medical@exergen.com
medical@exergen.com