MasimoSET® Accessory Ear Clip

GUDID 00843997001540

MASIMO CORPORATION

Pulse oximeter probe, reusable
Primary Device ID00843997001540
NIH Device Record Keyb7b42b4e-452c-4b11-a4d3-e5e9ec474ac2
Commercial Distribution StatusIn Commercial Distribution
Brand NameMasimoSET® Accessory Ear Clip
Version Model Number1606
Company DUNS780421038
Company NameMASIMO CORPORATION
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
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
Phone+1(949)297-7498
EmailTechService-US@masimo.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100843997001540 [Primary]

FDA Product Code

DPZOximeter, ear

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2016-09-24

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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

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