FDA.reportPublic FDA data

RD Sedline

Primary DI
10843997012802
Brand
RD Sedline
Company
MASIMO CORPORATION
Model
4329
Catalog number
4329
Device description
RD Sedline EEG Sensor Pediatric
Published
2023-08-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
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
10843997012802PrimaryGS10
00843997012805Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1084399701280210843997012802
00843997012805008439970128058439970128050843997012805

GMDN Terms#

Term, Definition table
TermDefinition
Analytical scalp electrode, single-useA noninvasive electrical conductor designed to be attached to the scalp surface of a patient to transmit changes in the electrical potential of various areas of the brain for recording/monitoring by a connected parent device [i.e., an electroencephalograph (EEG), sleep, or evoked potential recording device]. It typically consists of a small cup/disk with a conductive surface (e.g., tin, gold, conductive plastic) and a length of insulated connecting wire; it may be available as a set of multiple electrodes (e.g., EEG electrodes) however it is not a preconfigured EEG cap. This is a single-patient device that may be reapplied to the patient over a short term (single-use) before being discarded.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity5 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Handling Environment Temperature10 Degrees Celsius32 Degrees Celsius
Storage Environment Humidity5 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature10 Degrees Celsius32 Degrees Celsius

Contacts#

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

Regulatory Flags#

DUNS number
780421038
Device count
25
Lot or batch
true
Expiration date on label
true
No natural rubber latex
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
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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
00843997013475SedLineMASIMO CORPORATIONOLW2023-08-22
00843997013895SedLineMASIMO 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