DEVICE: Best Choice (00070038605164)
Device Identifier (DI) Information
Best Choice
KI-8160
In Commercial Distribution
VALU MERCHANDISERS COMPANY
KI-8160
In Commercial Distribution
VALU MERCHANDISERS COMPANY
A hand-held, battery-powered, electronic instrument designed to measure the temperature of a patient's ear canal using infrared radiation. It has a swivel head probe and an LCD display. This is a reusable device.
Device Characteristics
Labeling does not contain MRI Safety Information | |
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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? |
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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.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
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FLL | Thermometer, Electronic, Clinical |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
2831a246-e93d-4fd2-863b-1a61249cd718
March 29, 2018
2
September 20, 2016
March 29, 2018
2
September 20, 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 |
---|---|---|---|---|---|
40070038605162 | 4 | 20070038605168 | In Commercial Distribution | case | |
20070038605168 | 3 | 00070038605164 | In Commercial Distribution | inner carton |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
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Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
303-271-0300
info@180innovations.com
info@180innovations.com