Tommee Tippee Digital Ear Thermometer

GUDID 50666519700012

Infrared digital ear thermometer used for measuring body temperature

MAYBORN USA, INC.

Infrared patient thermometer, ear Infrared patient thermometer, ear Infrared patient thermometer, ear Infrared patient thermometer, ear Infrared patient thermometer, ear Infrared patient thermometer, ear Infrared patient thermometer, ear Infrared patient thermometer, ear Infrared patient thermometer, ear Infrared patient thermometer, ear Infrared patient thermometer, ear Infrared patient thermometer, ear Infrared patient thermometer, ear Infrared patient thermometer, ear Infrared patient thermometer, ear Infrared patient thermometer, ear Infrared patient thermometer, ear Infrared patient thermometer, ear Infrared patient thermometer, ear Infrared patient thermometer, ear
Primary Device ID50666519700012
NIH Device Record Key1617a708-60c7-4e55-96ec-0f36f593d569
Commercial Distribution StatusIn Commercial Distribution
Brand NameTommee Tippee Digital Ear Thermometer
Version Model NumberTH889SE
Company DUNS031274363
Company NameMAYBORN USA, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS150666519700012 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FLLThermometer, Electronic, Clinical

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2018-02-01

Devices Manufactured by MAYBORN USA, INC.

50666519700036 - Tommee Tippee Digital No Touch Thermomter2019-01-21 Tommee Tippee Digital No Touch Thermomter
50666519700012 - Tommee Tippee Digital Ear Thermometer2018-03-29Infrared digital ear thermometer used for measuring body temperature
50666519700012 - Tommee Tippee Digital Ear Thermometer2018-03-29 Infrared digital ear thermometer used for measuring body temperature

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