MasimoSET® rainbow® Extension Cable RC-EXT-8

GUDID 00843997008235

MASIMO CORPORATION

Electrical-only medical device connection cable, reusable
Primary Device ID00843997008235
NIH Device Record Key435855e8-8622-4651-b0d3-6a4e51003174
Commercial Distribution StatusIn Commercial Distribution
Brand NameMasimoSET® rainbow® Extension Cable RC-EXT-8
Version Model Number3659
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 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

Device Identifiers

Device Issuing AgencyDevice ID
GS100843997008235 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DQAOximeter

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2018-12-03
Device Publish Date2016-08-25

Devices Manufactured by MASIMO CORPORATION

10843997001448 - rainbow® R20 SpCO® SpO2 SpMet® Pediatric Pulse CO-Oximeter® Adhesive Sensor2025-12-22 rainbow R20 SpCO SpO2 SpMet Pediatric Pulse CO-Oximeter Adhesive Sensor
10843997001455 - rainbow®R20L SpCO® SpO2 SpMet® Infant Pulse CO-Oximeter® Adhesive Sensor2025-12-22 rainbowR20L SpCO SpO2 SpMet Infant Pulse CO-Oximeter® Adhesive Sensor
10843997001462 - MasimoSET® rainbow R25 SpCO SpO2 SpMet® Adult Pulse CO-Oximeter® Adhesive Sensor2025-12-22 MasimoSET rainbow R25 SpCO SpO2 SpMet Adult Pulse CO-Oximeter Adhesive Sensor
10843997001479 - rainbow R25-L SpCO SpO2 SpMet® Adult/Neonatal Pulse CO-Oximeter® Adhesive Sensor2025-12-22 rainbow R25-L SpCO SpO2 SpMet Adult/Neonatal Pulse CO-Oximeter Adhesive Sensor
10843997002322 - rainbow R1 25L SpHb SpO2 SpMet Adult/Neonatal Pulse CO-Oximeter Adhesive Sensor2025-12-22 rainbow R1 25L SpHb SpO2 SpMet Adult/Neonatal Pulse CO-Oximeter Adhesive Sensor
10843997002339 - R1 25 SpHb® SpO2, SpMet® Adult Pulse Co-Oximeter® Adhesive Sensor2025-12-22
10843997002346 - R1 20 Pediatric/Slender digit Pulse Co-Oximeter® Adhesive Sensor2025-12-22
10843997002353 - rainbow® R1 20L SpHb® SpO2 SpMet® Infant CO-Oximeter® Adhesive Sensor2025-12-22 rainbow R1 20L SpHb SpO2 SpMet Infant CO-Oximeter Adhesive Sensor

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.