FDA.reportPublic FDA data

Guaranteed Quality Products

Primary DI
00072000758359
Brand
Guaranteed Quality Products
Company
KMART HOLDING CORPORATION
Model
KD-120
Device description
A hand-held, battery-powered, electronic instrument designed for oral, under arm or rectal use to measure a patient's body temperature. The device has a rigid tip and an LCD display. It is designed to take a temperature reading in approximately 10 seconds. This is a reusable device.
Published
2016-09-20
Public version status
Update
Distribution status
Not 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
20072000758353PackageGS16Not in Commercial Distribution
40072000758357PackageGS124Not in Commercial Distribution
00072000758359PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2007200075835320072000758353
4007200075835740072000758357
00072000758359000720007583590720007583590072000758359

GMDN Terms#

Term, Definition table
TermDefinition
Intermittent electronic patient thermometerA hand-held, battery-powered, electronic instrument designed to measure a patient's body temperature. It may comprise an electronic unit with an attached probe or be a single unit (shaped like an ordinary hand-held capillary thermometer) that detects and converts the changes in temperature into variations of some electrical characteristic, e.g., resistance or voltage. These variations of the electrical characteristics are processed in the electronic circuits and in turn displayed, for a short period, as temperature readings. Thereafter the display will automatically turn off or go into standby mode. This is a reusable device.

Contacts#

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

Regulatory Flags#

DUNS number
131978533
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00072000783894Guaranteed Quality ProductsKD-1812016-09-20
00072000764978Guaranteed Quality ProductsKD-16312016-09-20
00883967296910Image Essentials One Step Pregnancy TestFPPL2016-07-04
00883967296927Image Essentials One Step Pregnancy TestFPPL2016-07-04
00072000793138Smart Sense Early Result Pregnancy TestPLPL2016-07-04
00883967382231Smart Sense TamponsBKMGR182016-09-20
00883967382248Smart Sense TamponsBKMSGR182016-09-20
00883967382255Smart Sense TamponsBKMSGS182016-09-20
00883967382262Smart Sense TamponsBKMGS182016-09-20
00883967418343SMART SENSE TamponsBKMGR362017-05-02
00883967418350SMART SENSE TamponsBKMUR182017-05-02
00883967418367SMART SENSE TamponsBKMSGP362017-05-02
00883967418374SMART SENSE TamponBKMPS502017-05-02
00883967418381SMART SENSE TamponsBKMXC362017-05-02
10883967382238Smart Sense TamponsBKMGR182016-09-20
10883967382245Smart Sense TamponsBKMSGR182016-09-20
10883967382252Smart Sense TamponsBKMSGS182016-09-20
10883967382269Smart Sense TamponsBKMGS182016-09-20
10883967418340SMART SENSE TamponsBKMGR362017-05-02
10883967418364SMART SENSE TamponsBKMSGP362017-05-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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