DEVICE: Tecnimed - BV Medical (00182097000054)
Device Identifier (DI) Information
Tecnimed - BV Medical
Thermofocus 0700
In Commercial Distribution
0700A2
TECNIMED SRL
Thermofocus 0700
In Commercial Distribution
0700A2
TECNIMED SRL
Infrared non contact thermometer intended for the intermittent measurement of human body temperature in people of all ages
Device Characteristics
Labeling does not contain MRI Safety Information | |
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GMDN
[?]GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.
GMDN Preferred Term Name | GMDN Definition |
---|---|
Infrared patient thermometer, skin | A hand-held, battery-powered, electronic 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. |
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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K072108 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Handling Environment Humidity: between 15 and 93 Percent (%) Relative Humidity |
Handling Environment Atmospheric Pressure: between 700 and 1060 millibar |
Handling Environment Temperature: between 10 and 45 Degrees Celsius |
Storage Environment Temperature: between -18 and 70 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
6b6b0ce8-6e84-4854-96f5-b94f111425cc
July 06, 2018
3
September 12, 2016
July 06, 2018
3
September 12, 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 |
---|---|---|---|---|---|
00182097000085 | 150 | 00182097000054 | In Commercial Distribution | box | |
00182097000092 | 50 | 00182097000054 | In Commercial Distribution | box | |
00182097000375 | 80 | 00182097000054 | In Commercial Distribution | 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