BEWELL CONNECT MyTens

GUDID 03760165449317

VISIOMED GROUP

Analgesic transcutaneous electrical nerve stimulation system
Primary Device ID03760165449317
NIH Device Record Key9a362329-305a-4b6c-9685-55712e09b8a7
Commercial Distribution StatusIn Commercial Distribution
Brand NameBEWELL CONNECT MyTens
Version Model NumberBW-TS1
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 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
GS103760165449317 [Primary]

FDA Product Code

NUHStimulator, Nerve, Transcutaneous, Over-The-Counter

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2019-10-23
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

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