Pulse oximeter

GUDID 00817746020151

BETTER BASICS, INC.

Pulse oximeter, battery-powered
Primary Device ID00817746020151
NIH Device Record Key40cfb1fa-25dc-4d9b-938a-60d000857cf4
Commercial Distribution StatusIn Commercial Distribution
Brand NamePulse oximeter
Version Model NumberMP-OX150-US
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 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
GS100817746020151 [Primary]
GS100817746020168 [Package]
Package: [1 Units]
In Commercial Distribution
GS100817746020175 [Package]
Contains: 00817746020168
Package: [200 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DQAOximeter

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 Date2016-11-18

On-Brand Devices [Pulse oximeter]

00817746021233MP-OX300
00817746020212MP-OX250-US
00817746020182MP-OX200-US
00817746020151MP-OX150-US

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