FDA.reportPublic FDA data

SedLine

Primary DI
00843997013895
Brand
SedLine
Company
MASIMO CORPORATION
Model
4497
Catalog number
4497
Device description
SedLine Module
Published
2023-08-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OLWIndex-Generating Electroencephalograph Software

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OLWIndex-Generating Electroencephalograph SoftwareNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K203113000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K203113000Masimo SedLine Sedation Monitor and AccessoriesMasimo Corporation2022-02-25OLW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00843997013895PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00843997013895008439970138958439970138950843997013895

GMDN Terms#

Term, Definition table
TermDefinition
Patient monitoring system module, electroencephalographicA small unit dedicated to detect and record the electrical activity of the brain in the form of an electroencephalogram (EEG). The electrical activity of the brain is detected via electrodes affixed to the patient's forehead or scalp. It is designed to operate as part of a patient monitoring system enhancing the function of this system (the parent device). The module automatically plugs into the parent device when the user places it into a standardized slot in the parent device which operates as a mainframe computer displaying the signals measured and provided by this module. It may also register auditory evoked potentials (AEP) signals.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(949)297-7498TechService-US@masimo.com

Regulatory Flags#

DUNS number
780421038
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10843997011003Radius VSM48422026-02-23
10843997016015Radius VSM46952026-02-23
00843997019163Radius VSM90372026-02-23
00843997019019Patient SafetyNet Lite950972026-02-23
00843997011006Radius VSM48422026-02-23
00843997016018Radius VSM46952026-02-23
00843997015530Rad-G YI Multisite Reusable Sensor46532021-10-08
10843997003381LNCS26902024-08-16
10843997003398LNCS26912024-08-16
10843997003404LNCS26922024-08-16
10843997003411LNCS26942024-08-16
10843997004968MasimoSET LNCS® E1™ SpO2 Adult Pulse Oximeter Adhesive Sensor291829182016-08-24
10843997010921RD rainbow SET-240282020-09-03
10843997010938RD rainbow SET-240292020-09-03
10843997013496O343842020-09-03
00843997010825rainbow SET418341832023-02-13
00843997010818rainbow SET41822022-11-21
10843997002797MasimoSET® LNCS® Adtx-3 SpO2 Adult Pulse Oximeter Adhesive Sensor260126012016-08-24
10843997002803MasimoSET® LNCS® Pdtx-3 SpO2 Pediatric Pulse Oximeter Adhesive Sensor260226022016-08-24
10843997002810MasimoSET® LNCS® Inf-3 SpO2 Infant Pulse Oximeter Adhesive Sensor260326032016-08-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840682147811CARESCAPE SoftwareGE Healthcare Finland OyOLW2026-04-15
00690103219395Smart Pressure ControllerEdwards Lifesciences LLCOLW2025-09-10
00690103219531Acumen IQ PlusEdwards Lifesciences LLCOLW2025-09-10
00690103219609VitaWaveEdwards Lifesciences LLCOLW2025-09-10
10841522108754UltraviewSLSPACELABS HEALTHCARE (WASHINGTON), INCOLW2024-05-13
10884521808270BISCovidien LPOLW2024-04-28
10884521808300BISCovidien LPOLW2024-04-28
10884521808317BISCovidien LPOLW2024-04-28
10884521533103BISCovidien LPOLW2024-03-01
00690103218848HemoSphere VitaEdwards Lifesciences LLCOLW2024-02-26
00690103218855HemoSphere VitaEdwards Lifesciences LLCOLW2024-02-26
10843997012802RD SedlineMASIMO CORPORATIONOLW2023-08-22
00843997013475SedLineMASIMO CORPORATIONOLW2023-08-22
00843997012805RD SedlineMASIMO CORPORATIONOLW2023-08-22
00195278522313CARESCAPE Canvas Smart DisplayGE Healthcare Finland OyOLW2023-04-19
00195278522320CARESCAPE Canvas 1000GE Healthcare Finland OyOLW2023-04-19
00195278523365CARESCAPE Canvas D19GE Healthcare Finland OyOLW2023-04-19
00195278524089NAGE Healthcare Finland OyOLW2023-04-19
10884521713055BISCovidien LPOLW2023-01-21
B746NS90101NeuroSENSENeurowave Systems Inc.OLW2022-10-21
10884521812376BISCovidien LPOLW2022-09-24
00840682146111CARESCAPE B650GE Healthcare Finland OyOLW2022-05-13
00840682146135CARESCAPE B450GE Healthcare Finland OyOLW2022-05-13
00840682146142CARESCAPE B850GE Healthcare Finland OyOLW2022-05-13
00840682146708NAGE Medical Systems Information Technologies, Inc.OLW2022-04-12
00840682146715NAGE Medical Systems Information Technologies, Inc.OLW2022-04-12
00840682146791NAGE Medical Systems Information Technologies, Inc.OLW2022-04-12
00840682147217NAGE Medical Systems Information Technologies, Inc.OLW2022-04-12
00840682147224NAGE Medical Systems Information Technologies, Inc.OLW2022-04-12
10884521533066BISCovidien LPOLW2021-12-24