Rad-57cm™ Pulse CO-Oximeter™

GUDID 00843997005289

MASIMO CORPORATION

Pulse Co-oximeter
Primary Device ID00843997005289
NIH Device Record Keyab3fdbfa-4055-4b81-8f61-c641a6ba8cfd
Commercial Distribution StatusIn Commercial Distribution
Brand NameRad-57cm™ Pulse CO-Oximeter™
Version Model Number9180
Company DUNS780421038
Company NameMASIMO CORPORATION
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 Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

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

Device Identifiers

Device Issuing AgencyDevice ID
GS100843997005289 [Primary]
GS100843997013758 [Direct Marking]

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 Date2018-11-30
Device Publish Date2016-09-21

On-Brand Devices [Rad-57cm™ Pulse CO-Oximeter™]

008439970064089062
008439970052899180

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