FDA.reportPublic FDA data

Forehead and Ear Thermometer

Primary DI
09351337000043
Brand
Forehead and Ear Thermometer
Company
GENERATION GUARD PTY LTD
Model
GM-400EF
Published
2016-09-28
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
09351337000067PackageGS150In Commercial Distribution
09351337000043PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09351337000067093513370000679351337000067
09351337000043093513370000439351337000043

GMDN Terms#

Term, Definition table
TermDefinition
Infrared patient thermometer, skinA hand-held, electrically-powered instrument designed to estimate the temperature of a site on the skin (e.g., axilla, forehead) by measurement of body infrared emissions at this particular point. It provides a method to determine temperature patterns or variations on the surface of the skin (e.g., due to differences in perfusion). This device may be used in the home. This is a reusable device.

Regulatory Flags#

DUNS number
743833861
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
09351337000029Ovulation and Pregnancy test KitGM-700PO2016-11-30
09351337000074Pregnancy testGM-700P2016-11-10
09351337000081Ovulation testGM-700O2016-11-10
09351337000005Digital ThermometerMT-43202016-09-30
09351337000012Basal ThermometerGM-300B2016-09-30
09351337000036Infrared Forehead thermometerGM-200F2016-09-20
09351337000067Forehead and Ear ThermometerGM-400EF2016-09-28
09351337000050Wrist Blood Pressure MonitorGM-500W2016-09-28
09351337000098Arm Blood Pressure MonitorGM-800A2017-02-20

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