O3™ Sensor rSO2 SpO2 Medium Adhesive Sensor

GUDID 10843997010020

MASIMO CORPORATION

Cerebral oximeter sensor, single-use
Primary Device ID10843997010020
NIH Device Record Keycfbe236e-e6fd-4e64-84fc-adfff50e5d2a
Commercial Distribution StatusIn Commercial Distribution
Brand NameO3™ Sensor rSO2 SpO2 Medium Adhesive Sensor
Version Model Number4193
Company DUNS780421038
Company NameMASIMO CORPORATION
Device Count20
DM Exemptfalse
Pre-market Exemptfalse
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 Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(949)297-7498
EmailTechService-US@masimo.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100843997010023 [Unit of Use]
GS110843997010020 [Primary]

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 Date2019-12-11
Device Publish Date2016-09-21

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00843997017480 - Masimo W12024-03-11 Masimo W1, Global, France
00843997017497 - Masimo W12024-03-11 Masimo W1, Global, German
00843997017503 - Masimo W12024-03-11 Masimo W1, Global, Switzerland
00843997017510 - Masimo W12024-03-11 Masimo W1, Global, Italy
00843997017527 - Masimo W12024-03-11 Masimo W1, Global, Sweden
00843997017534 - Masimo W12024-03-11 Masimo W1, Global, Netherlands

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