rainbow ReSposable Pulse CO-Oximeter Sensor System, pediatric/slender digit

GUDID 10843997007396

MASIMO CORPORATION

Pulse Co-oximeter probe, reusable
Primary Device ID10843997007396
NIH Device Record Keyd21dde0c-3013-4ba7-82a5-fbb527be40ad
Commercial Distribution StatusIn Commercial Distribution
Brand Namerainbow ReSposable Pulse CO-Oximeter Sensor System, pediatric/slender digit
Version Model Number3458
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 Kittrue
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

Device Identifiers

Device Issuing AgencyDevice ID
GS110843997007396 [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 Number5
Public Version Date2025-12-22
Device Publish Date2017-10-12

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

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