Fever Thermometer

GUDID 00817746021325

BETTER BASICS, INC.

Infrared patient thermometer, skin
Primary Device ID00817746021325
NIH Device Record Keydd4f8990-18a9-4c16-b006-482659a93bcb
Commercial Distribution StatusIn Commercial Distribution
Brand NameFever Thermometer
Version Model NumberMP-IRT450
Company DUNS013029698
Company NameBETTER BASICS, INC.
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-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100817746021325 [Package]
Contains: 00817746025552
Package: [100 Units]
In Commercial Distribution
GS100817746025552 [Package]
Contains: 00817746026665
Package: [1 Units]
In Commercial Distribution
GS100817746026665 [Primary]

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 Number4
Public Version Date2018-07-06
Device Publish Date2017-09-15

Devices Manufactured by BETTER BASICS, INC.

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00817746020038 - blood pressure monitor2019-11-08
00817746020069 - blood pressure monitor2019-11-08
00817746020090 - blood pressure monitor2019-11-08
00817746020120 - blood pressure monitor2019-11-08
00817746020151 - Pulse oximeter2018-07-06
00817746020182 - Pulse oximeter2018-07-06
00817746020212 - Pulse oximeter2018-07-06

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