FDA.reportPublic FDA data

N/A

Primary DI
00809148082714
Brand
N/A
Company
180 INNOVATIONS LLC
Model
KI-8271
Device description
A hand-held battery-powered electronic instrument designed to measure a patient's body temperature using infrared waves. The device has a infrared probe and an LCD display. It is designed to take a temperature reading in approximately 1 second. This is a reusable device.
Published
2019-04-24
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
00809148082714PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00809148082714008091480827148091480827140809148082714

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.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
126646582
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00809148200750BestmedHTD8813C2020-04-28
00809148200804PolygreenKI-82802020-04-28
40809148200758BestmedHTD8813C2020-04-28
20809148200808PolygreenKI-82802020-04-28
00809148243450Rite AidKD-2250.RA2018-03-07
00809148253329Rite AidKI-8271.RA2018-11-08
00809148317397Rite AidKD-235.RA2016-10-20
00809148322360Rite AidKI-8170L.RA2016-10-20
00809148323459Rite AidKD-2201L.RA2016-10-20
00809148428512Rite AidKD-2050.RA2016-10-20
00809148504322Rite AidKD-113.RA2016-10-20
00809148510699Rite AidKD-2050baby.RA2016-10-20
00809148528519Rite AidKD-1780FF.RA2018-10-25
00809148576138Rite AidKD-133baby.RA2016-10-20
00809148601694Rite AidKD-1780FFB.RA2018-10-25
00809148604237Rite Aid740.RA2016-10-20
00809148604329RITE AIDKD-1780-1.RA2018-03-17
00809148676135Rite AidKD-1780Baby.RA2018-03-17
00809148686066Rite AidKD-2280.RA2017-11-01
00809148704234Rite AidKD-1540.RA2018-03-09

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Primary DI, Brand, Company table
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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
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08698870325211FMTMETKO MEDIKAL VE TIBBI CIHAZLAR DIS TICARET LIMITED SIRKETIFLL2026-04-22