Little Journey

GUDID 06926408700165

The device is Non-Contact thermometer, which is intended to measure human body temperature

Shenzhen Dongdixin Technology Co.,Ltd.

Infrared patient thermometer, skin
Primary Device ID06926408700165
NIH Device Record Key356a4d08-0b79-471c-86ed-bda2dcff0c25
Commercial Distribution StatusIn Commercial Distribution
Brand NameLittle Journey
Version Model NumberKFT509
Company DUNS545301488
Company NameShenzhen Dongdixin Technology Co.,Ltd.
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 Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Device Identifiers

Device Issuing AgencyDevice ID
GS106926408700165 [Primary]
GS116926408700162 [Package]
Package: case [3 Units]
In Commercial Distribution

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 Number5
Public Version Date2018-08-31
Device Publish Date2017-10-16

On-Brand Devices [Little Journey ]

06926408700165The device is Non-Contact thermometer, which is intended to measure human body temperature
06926408700011The device is an Ear and forehead thermometer, which is intended to measure human body temperatu


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