Masimo Pulse Oximeter Probe

GUDID 10861317020481

LNCS Infant Probe-L

RENU MEDICAL, INC

Pulse oximeter probe, reprocessed
Primary Device ID10861317020481
NIH Device Record Key85c54f4c-c015-40eb-8144-51fbcf02e5e0
Commercial Distribution StatusIn Commercial Distribution
Brand NameMasimo Pulse Oximeter Probe
Version Model NumberRM-2319
Company DUNS100439103
Company NameRENU MEDICAL, INC
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchfalse
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100861317020484 [Primary]
GS110861317020481 [Package]
Contains: 00861317020484
Package: Case [20 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NLFOximeter, Reprocessed

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-05-17

On-Brand Devices [Masimo Pulse Oximeter Probe]

10861317020511LNCS Neonatal/Adult Probe
10861317020504LNCS Infant Probe
10861317020498LNCS Neonatal/Adult Probe-L
10861317020481LNCS Infant Probe-L
10861317020474LNCS Adult Probe-L
10861317020467LNCS Neonatal/Adult Probe-L 1862
10861317020450LNCS Infant Probe-L 1861
10861317020443LNCS Adult Probe
10816317020511LNCS Neonatal/Adult Probe
10816317020504LNCS Infant Probe
10816317020498LNCS Neonatal/Adult Probe-L
10816317020481LNCS Infant Probe-L
10816317020474LNCS Adult Probe-L
10816317020467LNCS Neonatal/Adult Probe-L 1862
10816317020450LNCS Infant Probe-L 1861
10816317020443LNCS Adult Probe

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