FDA.reportPublic FDA data

MasimoSET® M-LNCS™ TC-I SpO2 Reusable Ear Sensor

Primary DI
00843997003230
Brand
MasimoSET® M-LNCS™ TC-I SpO2 Reusable Ear Sensor
Company
MASIMO CORPORATION
Model
2503
Catalog number
2503
Device description
MasimoSET M-LNCS TC-I SpO2 Reusable Ear Sensor
Published
2016-08-24
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
DPZOximeter, ear

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DPZOximeter, EarCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K051212000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K051212000MODIFICATION TO LNCS OXIMETRY SENSORSMasimo Corporation2005-07-12DQA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00843997003230PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00843997003230008439970032308439970032300843997003230

GMDN Terms#

Term, Definition table
TermDefinition
Pulse oximeter probe, reusableA photoelectric device applied externally to a body site, e.g., a fingertip, ear lobe, the bridge of nose, a toe, or the bridge of the foot of a paediatric or adult patient for the transcutaneous measurement of haemoglobin oxygen saturation (SpO2) in arterial blood using light detection. The signals, typically produced by light-emitting diodes (LEDs) and a receiving detector, are received by an oximeter to which this device is connected. The oximeter displays the SpO2 values and may calculate/display other parameters, e.g., electrocardiogram (ECG). This is a reusable device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity5 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Handling Environment Temperature-40 Degrees Celsius70 Degrees Celsius
Storage Environment Humidity5 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature-40 Degrees Celsius70 Degrees Celsius

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
Lot or batch
true
Manufacturing 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 OyDPZ2026-04-15
00195278984784TruSignal SpO2GE Healthcare Finland OyDPZ2025-06-16
00860008683236OxiWearOXIWEAR, INC.DPZ2025-06-04
05700693918808TCM 4 series ETX base unitRadiometer Medical ApSDPZ2025-04-23
07640121880988103149 Calibration GasSenTec AGDPZ2024-07-05
07640121880995103164 tCOM+SenTec AGDPZ2024-07-05
07640121881008103420 Sensor Adapter Cable (Regular)SenTec AGDPZ2024-07-05
07640121881015103421 Sensor Adapter Cable (Long)SenTec AGDPZ2024-07-05
07640121881022103422 Sensor Adapter Cable (Extra Long)SenTec AGDPZ2024-07-05
00195278561312Portrait VSMGe Medical Systems Information Technologies, Inc.DPZ2024-05-05
07640121881039Non-Adhesive WrapSenTec AGDPZ2023-07-21
17640121881036Non-Adhesive WrapSenTec AGDPZ2023-07-21
00195278522313CARESCAPE Canvas Smart DisplayGE Healthcare Finland OyDPZ2023-04-19
00195278522320CARESCAPE Canvas 1000GE Healthcare Finland OyDPZ2023-04-19
00195278523365CARESCAPE Canvas D19GE Healthcare Finland OyDPZ2023-04-19
00195278524089NAGE Healthcare Finland OyDPZ2023-04-19
00195278288639CARESCAPE ONEGe Medical Systems Information Technologies, Inc.DPZ2022-05-13
00840682146111CARESCAPE B650GE Healthcare Finland OyDPZ2022-05-13
00840682146135CARESCAPE B450GE Healthcare Finland OyDPZ2022-05-13
00840682146142CARESCAPE B850GE Healthcare Finland OyDPZ2022-05-13
00840682146708NAGE Medical Systems Information Technologies, Inc.DPZ2022-04-12
00840682146715NAGE Medical Systems Information Technologies, Inc.DPZ2022-04-12
00840682146791NAGE Medical Systems Information Technologies, Inc.DPZ2022-04-12
00840682147217NAGE Medical Systems Information Technologies, Inc.DPZ2022-04-12
00840682147224NAGE Medical Systems Information Technologies, Inc.DPZ2022-04-12
07640121880964Patient Application Kit for mature intact skinSenTec AGDPZ2021-09-26
07640121880971Patient Application Kit for sensitive/fragile skinSenTec AGDPZ2021-09-26
07640121880957Patient Application Kit with Ear Clip for mature/intact skinSenTec AGDPZ2021-09-26
17640121880978Patient Application Kit for sensitive/fragile skinSenTec AGDPZ2021-09-26
00840682147248TruSignal SpO2GE Healthcare Finland OyDPZ2021-09-03