PULSOX-300

GUDID 00817770020608

Oximeter with Finger Probe

MAXTEC, LLC

Pulse oximeter, battery-powered
Primary Device ID00817770020608
NIH Device Record Key7c246a5a-b67a-4248-ae81-adba8cbc0df6
Commercial Distribution Discontinuation2019-05-06
Commercial Distribution StatusNot in Commercial Distribution
Brand NamePULSOX-300
Version Model NumberR204P16
Company DUNS169911828
Company NameMAXTEC, LLC
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 Numberfalse
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
GS100817770020608 [Primary]

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 Number5
Public Version Date2019-05-07
Device Publish Date2016-09-26

On-Brand Devices [PULSOX-300]

00817770020622Oximeter with Soft Tip Probe
00817770020615Oximeter with Spot Check Probe
00817770020608Oximeter with Finger Probe

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