BEWELL CONNECT MyThermo

GUDID 03760165440291

VISIOMED GROUP

Infrared patient thermometer, skin
Primary Device ID03760165440291
NIH Device Record Keyb0d536a6-a26b-4715-a705-70d1c6105e0d
Commercial Distribution StatusIn Commercial Distribution
Brand NameBEWELL CONNECT MyThermo
Version Model NumberBW-CX10
Company DUNS261118805
Company NameVISIOMED GROUP
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 Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS103760165440291 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FLLThermometer, Electronic, Clinical

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2020-12-04
Device Publish Date2017-04-28

Devices Manufactured by VISIOMED GROUP

03760165448167 - BEWELL CONNECT MyOxy2021-11-10
03700609705098 - THERMOFLASH2020-12-04
03700609705104 - THERMOFLASH2020-12-04
03700609705111 - THERMOFLASH2020-12-04
03700609705128 - THERMOFLASH2020-12-04
03700609705135 - THERMOFLASH2020-12-04
03700609705142 - THERMOFLASH2020-12-04
03760165440291 - BEWELL CONNECT MyThermo2020-12-04
03760165440291 - BEWELL CONNECT MyThermo2020-12-04

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