WROOTBOL NOTIPATCH

GUDID 18800105200157

Thermometer, colour-indicating

ONE POWER

Colour-indication patient thermometer Colour-indication patient thermometer Colour-indication patient thermometer Colour-indication patient thermometer Colour-indication patient thermometer Colour-indication patient thermometer Colour-indication patient thermometer Colour-indication patient thermometer Colour-indication patient thermometer Colour-indication patient thermometer Colour-indication patient thermometer Colour-indication patient thermometer Colour-indication patient thermometer Colour-indication patient thermometer Colour-indication patient thermometer Colour-indication patient thermometer Colour-indication patient thermometer Colour-indication patient thermometer Colour-indication patient thermometer Colour-indication patient thermometer Colour-indication patient thermometer Colour-indication patient thermometer Colour-indication patient thermometer Colour-indication patient thermometer Colour-indication patient thermometer Colour-indication patient thermometer Colour-indication patient thermometer Colour-indication patient thermometer Colour-indication patient thermometer Colour-indication patient thermometer Colour-indication patient thermometer
Primary Device ID18800105200157
NIH Device Record Key43d209e8-ca39-46a6-95a9-9eec1d90dae9
Commercial Distribution StatusIn Commercial Distribution
Brand NameWROOTBOL NOTIPATCH
Version Model NumberDR-TZ+365
Company DUNS694627986
Company NameONE POWER
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS108800105200150 [Primary]
GS118800105200157 [Package]
Contains: 08800105200150
Package: Cardboard Box [800 Units]
In Commercial Distribution

FDA Product Code

FQZThermometer, Clinical Color Change

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-05-25
Device Publish Date2021-05-17

Devices Manufactured by ONE POWER

18800105200157 - WROOTBOL NOTIPATCH2021-05-25Thermometer, colour-indicating
18800105200157 - WROOTBOL NOTIPATCH2021-05-25 Thermometer, colour-indicating
08800105200020 - Dr.Tempzone+2020-12-15 Thermometer, colour-indicating
08800105200037 - Dr.Tempzone+2020-12-15 Thermometer, colour-indicating
18800105200027 - Dr.Tempzone+2020-11-10 Thermometer, colour-indicating
18800105200034 - Dr.Tempzone+2020-11-10 Thermometer, colour-indicating

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