AccessGUDID - DEVICE: Tecnimed - BV Medical (00182097000054)

GUDID

Device Identifier (DI) Information

Brand Name: Tecnimed - BV Medical
Version or Model: Thermofocus 0700
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 0700A2
Company Name: TECNIMED SRL

Primary DI Number: 00182097000054
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 445878788 *Terms of Use

Device Description: Infrared non contact thermometer intended for the intermittent measurement of human body temperature in people of all ages

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	Yes
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

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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.

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

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Product Code	Product Code Name
FLL	Thermometer, Electronic, Clinical

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K072108	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

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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

Clinically Relevant Size

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Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 6b6b0ce8-6e84-4854-96f5-b94f111425cc
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 12, 2016

Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number	Quantity per Package	Contains DI Package	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