MasimoSET® LNOP® Neo-L SpO2 Neonatal/Adult Pulse Oximeter Adhesive Sensor

GUDID 10843997000144

MASIMO CORPORATION

Pulse oximeter probe, single-use
Primary Device ID10843997000144
NIH Device Record Keydc720e59-cc21-41b4-85f4-4b21876cbb4b
Commercial Distribution StatusIn Commercial Distribution
Brand NameMasimoSET® LNOP® Neo-L SpO2 Neonatal/Adult Pulse Oximeter Adhesive Sensor
Version Model Number1798
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
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
GS100843997000147 [Unit of Use]
GS110843997000144 [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 Date2021-11-10
Device Publish Date2016-08-23

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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

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