DEVICE: Ozeri (00815817014153)
Device Identifier (DI) Information
Ozeri
TH1-BL
In Commercial Distribution
COMMONPATH LLC
TH1-BL
In Commercial Distribution
COMMONPATH LLC
The Thermometer can display the result in either Fahrenheit or degree Celsius.
Colour - Black
How to use:
Steady and smoothly scroll the wheel either back and fourth or in one direction, so as to travel 12 inches or 30 cm.
The scrolling will kinetically charge the device.
Continue scroll the wheel until the LCD ON.
Position the thermometer at the distance of less than 1 inch for the center of the patients eyebrows.
Press and release the measure button.
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
No | |
No | |
No | |
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? |
---|---|---|---|---|
17887 | Infrared patient thermometer, ear |
A hand-held, battery-powered, electronic instrument designed to measure the temperature of a patient's ear canal. In most cases it is intended to estimate the internal (core) temperature of the body by measurement of infrared radiation from within the auditory canal. It may claim to measure directly the infrared emissions from the tympanic membrane. An infrared ear thermometer usually displays values corrected by an offset of actual patient oral/rectal temperatures. This is a reusable device.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
FLL | Thermometer, Electronic, Clinical |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
380db6dc-44bc-4c37-8319-f39f0b741e72
November 09, 2021
1
November 01, 2021
November 09, 2021
1
November 01, 2021
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
10815817014150 | 1 | 00815817014153 | In Commercial Distribution | Giftbox | |
20815817014157 | 40 | 10815817014150 | In Commercial Distribution | Carton box |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
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
[?]
18772991296
support@ozeri.com
support@ozeri.com