Tecnimed - Constant Care Technology

Basic Information

• Brand Name: Tecnimed - Constant Care Technology
• Primary DI: 00182097000191
• Version / Model: Thermofocus 0800
• Company Name: TECNIMED SRL
• Labeler DUNS: 445878788
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-03-30
• Public Version: 4
• Public Version Date: 2020-12-04
• Public Version Status: Update
• Public Device Record Key: 8de0a967-5d6e-4a2c-9817-7107154e7a32

Device Description

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

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FLL	Thermometer, Electronic, Clinical	General Hospital	880.2910	2

GMDN Terms

Code	Name	Definition	Implantable	Status
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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00182097000191	GS1
Package	00182097000207	GS1	carton box	50	In Commercial Distribution

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K072108	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: -18 – 70 Degrees Celsius
• Type: Handling Environment Temperature
• Temperature Range: 10 – 45 Degrees Celsius
• Type: Handling Environment Atmospheric Pressure
• Temperature Range: 700 – 1060 millibar
• Type: Handling Environment Humidity
• Temperature Range: 15 – 93 Percent (%) Relative Humidity