FDA.reportPublic FDA data

MEDLINE RENEWAL

Primary DI
10888277306363
Brand
MEDLINE RENEWAL
Company
MEDLINE INDUSTRIES, INC.
Model
1860R
Catalog number
1860R
Device description
LNCS PEDIATRIC PROBE
Published
2025-01-29
Public version status
New
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
NLFOximeter, reprocessed

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NLFOximeter, ReprocessedCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K191018000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K191018000Medline ReNewal Reprocessed Masimo LNCS Series Adult and Pediatric SpO2 Adhesive SensorsSurgical Instrument Service and Savings, Inc.2019-07-03NLF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
40888277306364PackageGS120In Commercial Distribution
10888277306363PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
4088827730636440888277306364
1088827730636310888277306363

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.

Contacts#

Phone, Email table
PhoneEmail
+1(800)633-5463service@medline.com

Regulatory Flags#

DUNS number
025460908
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10080196415397MEDLINEMSC97412MSC974122026-05-27
10653160393634MEDLINEDYNDV2733ADYNDV2733A2026-05-27
10653160393665MEDLINEDYNDV2772DYNDV27722026-05-27
10653160393689MEDLINEDYNDV2787DYNDV27872026-05-27
10653160393702MEDLINEDYNDV2783DYNDV27832026-05-27
10653160393719MEDLINEDYNDV2797DYNDV27972026-05-27
10653160393726MEDLINEDYNDC2483ADYNDC2483A2026-05-27
10653160393733MEDLINEDT22665ADT22665A2026-05-27
10888277415386MEDLINEMSC97410MSC974102026-05-27
10888277415393MEDLINEMSC9748MSC97482026-05-27
10888277677289MEDLINEMSC97414MSC974142026-05-27
10888277677296MEDLINEMSC9746MSC97462026-05-27
10888277177680MEDLINEMDSMR117MDSMR1172021-05-14
10884389120620MEDLINEMDSMR112MDSMR1122021-04-23
10884389120675MEDLINEMDSMPHS2MDSMPHS22021-04-23
10884389128756MEDLINEMDSMR113MDSMR1132021-04-23
10884389177679MEDLINEMDSMPHS1MDSMPHS12021-04-23
10653160393306MEDLINEDYND74299DYND742992026-05-26
10080196031214MEDLINEDYND13515DYND135152021-02-19
10080196032143MEDLINEDYND30331DYND303312022-03-29

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
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
00816317023492MasimoRENU MEDICAL, INCNLF2023-06-29
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