FDA.reportPublic FDA data

Rite Aid

Primary DI
40809148322368
Brand
Rite Aid
Company
180 INNOVATIONS LLC
Model
KI-8170L.RA
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
2016-10-20
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

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
20809148322364PackageGS13Not in Commercial Distribution
40809148322368PackageGS14Not in Commercial Distribution
00809148322360PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2080914832236420809148322364
4080914832236840809148322368
00809148322360008091483223608091483223600809148322360

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
+1(303)271-0300info@180innovations.com

Regulatory Flags#

DUNS number
126646582
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
00809148082714N/AKI-82712019-04-24
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

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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B3945700068020WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.FLL2026-05-27
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