Pulse Oximeter

GUDID 00817746021233

BETTER BASICS, INC.

Pulse oximeter, battery-powered
Primary Device ID00817746021233
NIH Device Record Keyb80aa21c-27fd-4a70-8456-bc7687e42cdd
Commercial Distribution StatusIn Commercial Distribution
Brand NamePulse Oximeter
Version Model NumberMP-OX300
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
GS100817746021226 [Primary]
GS100817746021233 [Package]
Contains: 00817746028874
Package: [100 Units]
In Commercial Distribution
GS100817746028874 [Package]
Contains: 00817746021226
Package: [1 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 Number4
Public Version Date2018-07-06
Device Publish Date2017-09-15

On-Brand Devices [Pulse Oximeter]

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

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.