MasimoSET® Standard Multisite Wrap

GUDID 10843997000335

MASIMO CORPORATION

Basic skin adhesive tape
Primary Device ID10843997000335
NIH Device Record Keye75bbff7-aed3-4142-9017-61c340195325
Commercial Distribution StatusIn Commercial Distribution
Brand NameMasimoSET® Standard Multisite Wrap
Version Model Number1597
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100843997000338 [Unit of Use]
GS110843997000335 [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 Date2019-10-23
Device Publish Date2016-08-23

Devices Manufactured by MASIMO CORPORATION

00843997016551 - Home Health Kit2024-09-17 Home Health Kit
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

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