Philips ear thermometer

GUDID 00075020054043

Shenzhen Dongdixin Technology Co.,Ltd.

Infrared patient thermometer, ear
Primary Device ID00075020054043
NIH Device Record Key44a2b7b1-6ba0-4289-839c-a98f96676f65
Commercial Distribution StatusIn Commercial Distribution
Brand NamePhilips ear thermometer
Version Model NumberDL8740
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 Batchfalse
Serial Numbertrue
Manufacturing Datefalse
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
GS100075020054043 [Primary]
GS120075020053309 [Package]
Package: [4 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 Number3
Public Version Date2018-07-06
Device Publish Date2016-09-24

Devices Manufactured by Shenzhen Dongdixin Technology Co.,Ltd.

06926408700455 - CARETALK2020-04-15 The device is Non-Contact thermometer, which is intended to measure human body temperature
16926408700209 - CARETALK2020-03-27 The device is Non-Contact thermometer, which is intended to measure human body temperature
06926408710317 - Welby2019-10-23 3 IN 1: TENS, EMS AND MASSAGE DEVICE
06926408700165 - Little Journey 2018-08-31 The device is Non-Contact thermometer, which is intended to measure human body temperature
20075020053293 - Philips Avent ear thermometer2018-08-20
06926408700011 - Little Journey 2018-07-06 The device is an Ear and forehead thermometer, which is intended to measure human body temperature.
00075020054043 - Philips ear thermometer2018-07-06
00075020054043 - Philips ear thermometer2018-07-06

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