FDA.reportPublic FDA data

Masimo

Primary DI
00816317023492
Brand
Masimo
Company
RENU MEDICAL, INC
Model
RM-2321
Device description
LNCS Neonatal/Adult Probe-L 2321
Published
2023-06-29
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
NLFOximeter, Reprocessed

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NLFOximeter, ReprocessedCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K081927000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K081927000RENU MEDICAL OXIMETRY SENSOR, ADULT, PED, INF,NEORenu Medical, Inc.2009-02-06NLF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10816317023499PackageGS120In Commercial Distribution
00816317023492PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081631702349910816317023499
00816317023492008163170234928163170234920816317023492

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.

Regulatory Flags#

DUNS number
100439103
Device count
1
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00816317024420Kendall DVT SleeveRM-830222026-01-27
00816317024437Kendall DVT SleeveRM-830232026-01-27
00816317024444Kendall DVT SleeveRM-830242026-01-27
10816317024427Kendall DVT SleeveRM-830222026-01-27
10816317024434Kendall DVT SleeveRM-830232026-01-27
10816317024441Kendall DVT SleeveRM-830242026-01-27
00816317024413HoverMatt Lateral Transfer MatRM-HM34SPU-SPLIT-B2025-10-30
00816317023997Nellcor Pulse Oximeter ProbeRM-MAX-P2025-07-08
10816317023994Nellcor Pulse Oximeter ProbeRM-MAX-P2025-07-08
00816317024307Kendall ECG LeadsRM-33136R362025-05-01
00816317024321Kendall ECG LeadsRM-33136RT722025-05-01
00816317024338Kendall ECG LeadsRM-33136RT362025-05-01
00816317024345Kendall ECG LeadsRM-33137T2025-05-01
00816317024352Kendall ECG LeadsRM-331132025-05-01
00816317024369Kendall ECG LeadsRM-33154T2025-05-01
00816317024291Kendall ECG LeadsRM-33114N2025-05-01
10816317024304Kendall ECG LeadsRM-33136R362025-05-01
00816317024314Kendall ECG LeadsRM-33136R722025-05-01
10816317024328Kendall ECG LeadsRM-33136RT722025-05-01
10816317024335Kendall ECG LeadsRM-33136RT362025-05-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00816317023997Nellcor Pulse Oximeter ProbeRENU MEDICAL, INCNLF2025-07-08
10816317023994Nellcor Pulse Oximeter ProbeRENU MEDICAL, INCNLF2025-07-08
10193489020458MEDLINEMEDLINE INDUSTRIES, INC.NLF2025-01-29
10884389185339MEDLINE RENEWALMEDLINE INDUSTRIES, INC.NLF2025-01-29
10884389185346MEDLINE RENEWALMEDLINE INDUSTRIES, INC.NLF2025-01-29
10888277185326MEDLINE RENEWALMEDLINE INDUSTRIES, INC.NLF2025-01-29
10888277306356MEDLINE RENEWALMEDLINE INDUSTRIES, INC.NLF2025-01-29
10888277306363MEDLINE RENEWALMEDLINE INDUSTRIES, INC.NLF2025-01-29
10193489020441MEDLINEMEDLINE INDUSTRIES, INC.NLF2025-01-02
20193489020448MEDLINEMEDLINE INDUSTRIES, INC.NLF2025-01-02
10888277722309MedlineMEDLINE INDUSTRIES, INC.NLF2023-10-09
20888277722306MedlineMEDLINE INDUSTRIES, INC.NLF2023-10-09
00816317024109Pulse Oximeter ProbeRENU MEDICAL, INCNLF2023-08-21
10816317024106Pulse Oximeter ProbeRENU MEDICAL, INCNLF2023-08-21
00816317023973MasimoRENU MEDICAL, INCNLF2023-06-29
10816317023499MasimoRENU MEDICAL, INCNLF2023-06-29
10816317023970MasimoRENU MEDICAL, INCNLF2023-06-29
07613327610543Stryker Sustainability SolutionsSTRYKER SUSTAINABILITY SOLUTIONS, INC.NLF2023-02-07
07613327610550Stryker Sustainability SolutionsSTRYKER SUSTAINABILITY SOLUTIONS, INC.NLF2023-02-07
07613327610567Stryker Sustainability SolutionsSTRYKER SUSTAINABILITY SOLUTIONS, INC.NLF2023-02-07
07613327610574Stryker Sustainability SolutionsSTRYKER SUSTAINABILITY SOLUTIONS, INC.NLF2023-02-07
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
10817357020011NellcorHYGIA HEALTH SERVICES, INC.NLF2016-09-24
10817357020028NellcorHYGIA HEALTH SERVICES, INC.NLF2016-09-24
10817357020059MasimoHYGIA HEALTH SERVICES, INC.NLF2016-09-24
10817357020097MasimoHYGIA HEALTH SERVICES, INC.NLF2016-09-24
10817357020141NellcorHYGIA HEALTH SERVICES, INC.NLF2016-09-24