FDA.reportPublic FDA data

Best Choice

Primary DI
00070038605164
Brand
Best Choice
Company
VALU MERCHANDISERS COMPANY
Model
KI-8160
Device description
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.
Published
2016-09-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FLLThermometer, Electronic, Clinical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FLLContinuous Measurement ThermometerGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20070038605168PackageGS13In Commercial Distribution
40070038605162PackageGS14In Commercial Distribution
00070038605164PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2007003860516820070038605168
4007003860516240070038605162
00070038605164000700386051640700386051640070038605164

GMDN Terms#

Term, Definition table
TermDefinition
Infrared patient thermometer, earA 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.

Contacts#

Phone, Email table
PhoneEmail
303-271-0300info@180innovations.com

Regulatory Flags#

DUNS number
868703513
Device count
1
Lot or batch
true

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