RD SedLine 5109

GUDID 00843997000581

RD SedLine EEG Sensor, Pediatric

MASIMO CORPORATION

Analytical scalp electrode, single-use
Primary Device ID00843997000581
NIH Device Record Key319293ca-5bfc-4c5a-a9a9-78edd7c4cacd
Commercial Distribution StatusIn Commercial Distribution
Brand NameRD SedLine
Version Model Number5109
Catalog Number5109
Company DUNS780421038
Company NameMASIMO CORPORATION
Device Count25
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
Phone+1(949)297-7498
EmailTechService-US@masimo.com
Phone+1(949)297-7498
EmailTechService-US@masimo.com

Operating and Storage Conditions

Handling Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 32 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 32 Degrees Celsius
Handling Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 32 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 32 Degrees Celsius
Handling Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 32 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 32 Degrees Celsius
Handling Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 32 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 32 Degrees Celsius
Handling Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 32 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 32 Degrees Celsius
Handling Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 32 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 32 Degrees Celsius
Handling Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 32 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 32 Degrees Celsius
Handling Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 32 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 32 Degrees Celsius
Handling Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 32 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 32 Degrees Celsius
Handling Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 32 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 32 Degrees Celsius
Handling Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 32 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 32 Degrees Celsius
Handling Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 32 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 32 Degrees Celsius
Handling Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 32 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 32 Degrees Celsius
Handling Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 32 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 32 Degrees Celsius
Handling Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 32 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 32 Degrees Celsius
Handling Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 32 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 32 Degrees Celsius
Handling Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 32 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 32 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100843997000581 [Unit of Use]
GS110843997000588 [Primary]

FDA Product Code

GXYElectrode, Cutaneous

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-02-27
Device Publish Date2023-02-17

On-Brand Devices [RD SedLine]

10843997011775EEG Sensor Adult
00843997012485RD Sedline Patient Cable
00843997000581RD SedLine EEG Sensor, Pediatric
00843997012805RD Sedline EEG Sensor Pediatric

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