FDA.reportPublic FDA data

Baby Basics

Primary DI
00041163495821
Brand
Baby Basics
Company
SUPERVALU INC.
Model
KI-8170L
Device description
A hand-held, battery-powered, electronic instrument designed to measure a patient's body temperature from the inner ear. The device has an infrared probe and an LCD display. It is designed to take a temperature reading in approximately 5 seconds. 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
20041163495825PackageGS13In Commercial Distribution
40041163495829PackageGS14In Commercial Distribution
00041163495821PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2004116349582520041163495825
4004116349582940041163495829
00041163495821000411634958210411634958210041163495821

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
006961411
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00041163500648Equaline0411635006482020-05-29
00041163498174EqualineALB4145ALB41452025-10-09
00041163250925Equaline7W926ELC22022-10-11
00041163503885EqualineKD-20502023-09-05
20041163503889EqualineKD-20502023-09-05
10041163250922Equaline7W926ELC22022-10-11
00041163263352Equaline TamponsBSVAR402016-09-20
00041163263369Equaline TamponsBSVAS402016-09-20
00041163263383Equaline TamponsBSVAC402016-09-20
00041163444164Equaline TamponsBSVGC362016-09-20
00041163471559Equaline TamponsBSVGS182016-09-20
00041163497306Equaline TamponsBSVUR182016-09-20
00041163497313Equaline TamponsBSVUS182016-09-20
00041163497344Equaline TamponsBSVGS362016-09-20
00041163497368Equaline TamponsBSVGR362016-09-20
00041163497375Equaline TamponsBSVGR182016-09-20
00041163499133Equaline TamponsBSVXR182017-05-02
00041163499140Equaline TamponsBSVXS182017-05-02
00041163499157Equaline TamponsBSVXC182017-05-02
00041163450240Equaline0411634502402020-05-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06972040114334N/AShenzhen AOJ Medical Technology Co., LtdFLL2026-07-11
06972040114341N/AShenzhen AOJ Medical Technology Co., LtdFLL2026-07-11
06972040115522N/AShenzhen AOJ Medical Technology Co., LtdFLL2026-07-11
06931973457093CaremedShenzhen Caremed Medical Technology Co., Ltd.FLL2026-07-09
06931973457109CaremedShenzhen Caremed Medical Technology Co., Ltd.FLL2026-07-09
06970758502641CaremedShenzhen Caremed Medical Technology Co., Ltd.FLL2026-07-09
06970758508865CaremedShenzhen Caremed Medical Technology Co., Ltd.FLL2026-07-09
00850086928008SENSINEL™ CPM BASE STATIONAnalog Devices, Inc.FLL2026-06-03
00850086928015SENSINEL™ CPM WEARABLEAnalog Devices, Inc.FLL2026-06-03
00850086928022SENSINEL™ CARDIOPULMONARY MANAGEMENT (CPM) SYSTEM)Analog Devices, Inc.FLL2026-06-03
00850086928039SENSINEL™ CARDIOPULMONARY MANAGEMENT (CPM) SYSTEM)Analog Devices, Inc.FLL2026-06-03
08720256776567Corsano CardioWatch 287-2 SystemCorsano Health B.V.FLL2026-06-02
06926347900459joybabeShenzhen Brav Electronic Technologies Co., Ltd.FLL2026-06-01
06942284618073One Step®JOYTECH HEALTHCARE CO.,LTDFLL2026-05-29
00884392020613Safety 1stDOREL JUVENILE GROUP, INC.FLL2026-05-28
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B3945700048060WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.FLL2026-05-27
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B3945700048080WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.FLL2026-05-27