FDA.reportPublic FDA data

MEDLINE

Primary DI
20193489020448
Brand
MEDLINE
Company
MEDLINE INDUSTRIES, INC.
Model
2317R
Catalog number
2317R
Device description
2317 @LNCS ADULT PULSE OX SENSOR 3FT
Published
2025-01-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
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
20193489020448PackageGS120In Commercial Distribution
10193489020441PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2019348902044820193489020448
1019348902044110193489020441

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(800)633-5463service@medline.com

Regulatory Flags#

DUNS number
025460908
Device count
1
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
false
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
10888277419452MEDLINEMDTZ1068516ABMDTZ1068516AB2016-10-14
00888277719081RexallDG11009803DG110098032026-06-03
10884389106303MEDLINEDYND20323DYND203232021-01-05
10888277656970MEDLINEDYND50221NSDYND50221NS2021-01-02
10888277656987MEDLINEDYND50223NSDYND50223NS2021-01-02
10888277657007MEDLINEDYND50252NSDYND50252NS2021-01-02
10888277658325MEDLINEOR712NSOR712NS2021-01-02
10888277694507MEDLINEDYND50251NSDYND50251NS2021-01-02
10888277694514MEDLINEDYND50253NS1DYND50253NS12021-01-02
10888277725157MEDLINEEQX2377EQX23772023-12-15
10080196000630Teleflex/Hudson RCI540254022016-04-08
10080196003648Teleflex/Hudson RCI2700-2052700-2052016-04-08
10080196986217Teleflex/Hudson RCI540354032016-04-08
10193489078022NAMICH74904487202H749044872022022-02-24
10812564036022MedlineSYN3000SYN30002026-03-11
10812564036077MedlineSYN3004SYN30042026-03-11
10812564036107MedlineSYN3015SYN30152026-03-11
10812564036183MedlineSYN3020SYN30202026-03-11
10812564036190MedlineSYN3025SYN30252026-03-11
10812564036213MedlineSYN3030SYN30302026-03-11

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
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