FDA.reportPublic FDA data

MasimoSET Reprocessed LNCS® Adtx SpO2 Adult Pulse Oximeter Adhesive Sensor

Primary DI
10843997003350
Brand
MasimoSET Reprocessed LNCS® Adtx SpO2 Adult Pulse Oximeter Adhesive Sensor
Company
MASIMO CORPORATION
Model
2686
Published
2016-08-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NLFOXIMETER, REPROCESSED

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NLFOximeter, ReprocessedCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10843997003350PrimaryGS10
00843997003353Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1084399700335010843997003350
00843997003353008439970033538439970033530843997003353

GMDN Terms#

Term, Definition table
TermDefinition
Pulse oximeter probe, reprocessedA photoelectric device designed to be applied externally to a body site (e.g., fingertip, ear lobe, bridge of nose, toe, or bridge of the foot) for the transcutaneous measurement of haemoglobin oxygen saturation (SpO2) in arterial blood using signals produced by a light-emitting diode (LED) and received by a photodetector. The signals are subsequently transmitted to an oximeter/monitor (not included) which measures and displays the SpO2. This is a single-use device that has previously been used on a patient and has been subjected to additional processing and manufacturing for an additional single-use patient application.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
780421038
Device count
20
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00843997019019Patient SafetyNet Lite950972026-02-23
00843997011006Radius VSM48422026-02-23
00843997016018Radius VSM46952026-02-23
00843997010825rainbow SET418341832023-02-13
10843997001448rainbow® R20 SpCO® SpO2 SpMet® Pediatric Pulse CO-Oximeter® Adhesive Sensor222222222016-08-23
10843997001455rainbow®R20L SpCO® SpO2 SpMet® Infant Pulse CO-Oximeter® Adhesive Sensor222022202016-08-23
10843997001462MasimoSET® rainbow R25 SpCO SpO2 SpMet® Adult Pulse CO-Oximeter® Adhesive Sensor222122212016-08-23
10843997001479rainbow R25-L SpCO SpO2 SpMet® Adult/Neonatal Pulse CO-Oximeter® Adhesive Sensor221922192016-08-23
10843997002322rainbow R1 25L SpHb SpO2 SpMet Adult/Neonatal Pulse CO-Oximeter Adhesive Sensor241424142016-08-24
10843997002339R1 25 SpHb® SpO2, SpMet® Adult Pulse Co-Oximeter® Adhesive Sensor37922016-08-25
10843997002346R1 20 Pediatric/Slender digit Pulse Co-Oximeter® Adhesive Sensor37932016-08-25
10843997002353rainbow® R1 20L SpHb® SpO2 SpMet® Infant CO-Oximeter® Adhesive Sensor241524152016-08-24
10843997003701rainbow ReSposable R2-20a Pediatric/Slender Digit Pulse CO-Oximeter Sensor27552017-10-06
10843997003725rainbow ReSposable, R2-25a, Adult Pulse CO-Oximeter Disposable Optical Sensor27532017-10-06
10843997004067MasimoSET® Rainbow Adult Sensor Sample Pack22912016-08-23
10843997004074MasimoSET® Rainbow Ped/Inf Sensor Sample Pack22922016-08-23
10843997007181R2-25r SpHb SpO2 SpMet Adult Pulse CO-Oximeter Reusable Optical Sensor (ROS)33952016-08-24
10843997007198R2-20r Pediatric/Slender digit Pulse CO-Oximeter Reusable Optical Sensor (ROS)34112016-08-24
10843997007389rainbow ReSposable Pulse CO-Oximeter Sensor System, Adult34572017-10-12
10843997007396rainbow ReSposable Pulse CO-Oximeter Sensor System, pediatric/slender digit34582017-10-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10816317023994Nellcor Pulse Oximeter ProbeRENU MEDICAL, INCNLF2025-07-08
20193489020448MEDLINEMEDLINE INDUSTRIES, INC.NLF2025-01-02
20888277722306MedlineMEDLINE INDUSTRIES, INC.NLF2023-10-09
10816317024106Pulse Oximeter ProbeRENU MEDICAL, INCNLF2023-08-21
10816317023499MasimoRENU MEDICAL, INCNLF2023-06-29
10816317023970MasimoRENU MEDICAL, INCNLF2023-06-29
37613327610544Stryker Sustainability SolutionsSTRYKER SUSTAINABILITY SOLUTIONS, INC.NLF2023-02-07
57613327610555Stryker Sustainability SolutionsSTRYKER SUSTAINABILITY SOLUTIONS, INC.NLF2023-02-07
57613327610562Stryker Sustainability SolutionsSTRYKER SUSTAINABILITY SOLUTIONS, INC.NLF2023-02-07
57613327610579Stryker Sustainability SolutionsSTRYKER SUSTAINABILITY SOLUTIONS, INC.NLF2023-02-07
20884522042045NellcorCovidien LPNLF2016-09-24
30817357020015NellcorHYGIA HEALTH SERVICES, INC.NLF2016-09-24
30817357020022NellcorHYGIA HEALTH SERVICES, INC.NLF2016-09-24
30817357020053MasimoHYGIA HEALTH SERVICES, INC.NLF2016-09-24
30817357020091MasimoHYGIA HEALTH SERVICES, INC.NLF2016-09-24
30817357020145NellcorHYGIA HEALTH SERVICES, INC.NLF2016-09-24
30817357020183MasimoHYGIA HEALTH SERVICES, INC.NLF2016-09-24
30817357020299NellcorHYGIA HEALTH SERVICES, INC.NLF2016-09-24
30817357020336MasimoHYGIA HEALTH SERVICES, INC.NLF2016-09-24
30817357020343NellcorHYGIA HEALTH SERVICES, INC.NLF2016-09-24
30817357020466MasimoHYGIA HEALTH SERVICES, INC.NLF2016-09-24
30817357020619NellcorHYGIA HEALTH SERVICES, INC.NLF2016-09-24
30817357020725MasimoHYGIA HEALTH SERVICES, INC.NLF2016-09-24
30817357020817NellcorHYGIA HEALTH SERVICES, INC.NLF2016-09-24
30817357020978MasimoHYGIA HEALTH SERVICES, INC.NLF2016-09-24
30817357021418MasimoHYGIA HEALTH SERVICES, INC.NLF2016-09-24
10884522040105NellcorCovidien LPNLF2016-09-24
10884522040891NellcorCovidien LPNLF2016-09-24
10884522042185NellcorCovidien LPNLF2016-09-24
10884522042277NellcorCovidien LPNLF2016-09-24