Radical Docking Station RDS-3 signal extraction pulse oximeter

GUDID 00843997006040

MASIMO CORPORATION

Pulse oximeter, line-powered
Primary Device ID00843997006040
NIH Device Record Key7f156b36-b9a1-4dd3-831e-ebda22ad69fc
Commercial Distribution StatusIn Commercial Distribution
Brand NameRadical Docking Station RDS-3 signal extraction pulse oximeter
Version Model Number9171
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
GS100843997006040 [Primary]
GS100843997013819 [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 Date2018-11-29
Device Publish Date2016-09-21

On-Brand Devices [Radical Docking Station RDS-3 signal extraction pulse oximeter]

008439970060579172
008439970060409171

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