Masimo Sensor

GUDID 00843997016797

Masimo Sensor Replacement

MASIMO CORPORATION

Pulse Co-oximeter
Primary Device ID00843997016797
NIH Device Record Keyb58f9a99-5d50-4dbf-a0ce-5ef04b5ae7eb
Commercial Distribution StatusIn Commercial Distribution
Brand NameMasimo Sensor
Version Model Number4935
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 Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
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
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
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
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
Phone+1(949)297-7498
EmailTechService-US@masimo.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100843997016797 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MWIMonitor, physiological, patient (without arrhythmia detection or alarms)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-10-18
Device Publish Date2021-10-08

Devices Manufactured by MASIMO CORPORATION

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00843997017442 - Radius PPG2024-09-17 Masimo SafetyNet, Radius PPG Chip
00843997009065 - Radius VSM2024-08-27 Radius VSM Multi-functional Reusable Pod, 1/Box
00843997009430 - Radius VSM2024-08-27 Radius VSM NIBP Module, 1/Box
00843997010337 - Radius VSM2024-08-27 Radius VSM Kit with Reusable Pod & NIBP
00843997009263 - Radius VSM2024-08-27 Radius VSM Kit with NIBP
00843997006187 - Radius VSM2024-08-27 Radius VSM RAS-45 Acoustic Respiration Sensor, Adult, 10/Box
00843997006989 - Radius VSM2024-08-27 Radius VSM Disposable NIBP Cuff, Small Adult, 20/box

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