DEVICE: Tecnimed - BV Medical (00182097000054)

Device Identifier (DI) Information

Tecnimed - BV Medical
Thermofocus 0700
In Commercial Distribution
0700A2
TECNIMED SRL
00182097000054
GS1

1
445878788 *Terms of Use
Infrared non contact thermometer intended for the intermittent measurement of human body temperature in people of all ages
CLOSE

Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
No
Yes
No
No
No

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.
CLOSE

FDA Product Code

[?]
Product Code Product Code Name
FLL Thermometer, Electronic, Clinical
CLOSE

FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K072108 000
No CLOSE

Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
CLOSE

Storage and Handling

[?]
Storage and Handling
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
CLOSE

Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
CLOSE

Device Record Status

6b6b0ce8-6e84-4854-96f5-b94f111425cc
July 06, 2018
3
September 12, 2016
CLOSE

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
CLOSE

Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
CLOSE

Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
CLOSE

Production Identifier(s) in UDI

[?]
Yes
No
No
No
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
CLOSE