MasimoSET® Replacement Tapes for LNOPv Ne Sensors

GUDID 10843997000380

MASIMO CORPORATION

Pulse oximeter probe, single-use Pulse oximeter probe, single-use Pulse oximeter probe, single-use Pulse oximeter probe, single-use Pulse oximeter probe, single-use Pulse oximeter probe, single-use Pulse oximeter probe, single-use Pulse oximeter probe, single-use Pulse oximeter probe, single-use Pulse oximeter probe, single-use Pulse oximeter probe, single-use Pulse oximeter probe, single-use Pulse oximeter probe, single-use Pulse oximeter probe, single-use Pulse oximeter probe, single-use
Primary Device ID10843997000380
NIH Device Record Keyd53d9e4d-6c53-4140-b09f-5ac41848e3fd
Commercial Distribution StatusIn Commercial Distribution
Brand NameMasimoSET® Replacement Tapes for LNOPv Ne Sensors
Version Model Number1799
Company DUNS780421038
Company NameMASIMO CORPORATION
Device Count100
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
GS100843997000383 [Unit of Use]
GS110843997000380 [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

Devices Manufactured by MASIMO CORPORATION

00843997017688 - Nomoline2024-03-27 NomoLine LH Bypass Tubing, 3m
00843997005364 - Masimo W12024-03-11 Masimo W1, Tele-Health, Global
00843997017480 - Masimo W12024-03-11 Masimo W1, Global, France
00843997017497 - Masimo W12024-03-11 Masimo W1, Global, German
00843997017503 - Masimo W12024-03-11 Masimo W1, Global, Switzerland
00843997017510 - Masimo W12024-03-11 Masimo W1, Global, Italy
00843997017527 - Masimo W12024-03-11 Masimo W1, Global, Sweden
00843997017534 - Masimo W12024-03-11 Masimo W1, Global, Netherlands

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.