Nellcor Pulse Oximeter Probe

GUDID 10861317020566

Nellcor OxiMax MAX-N NEONATAL/ADULT

RENU MEDICAL, INC

Pulse oximeter probe, reprocessed
Primary Device ID10861317020566
NIH Device Record Key7bff734f-3a8c-4574-90e6-0165df07d9a0
Commercial Distribution StatusIn Commercial Distribution
Brand NameNellcor Pulse Oximeter Probe
Version Model NumberRM-MAX-N
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
GS100861317020569 [Primary]
GS110861317020566 [Package]
Contains: 00861317020569
Package: CASE [24 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 Date2016-08-23

On-Brand Devices [Nellcor Pulse Oximeter Probe]

10861317020566Nellcor OxiMax MAX-N NEONATAL/ADULT
10861317020559Nellcor OxiMax MAX-I INFANT
10861317020542Nellcor OxiMax MAX-AL ADULT
10861317020535Nellcor OxiMax MAX-A ADULT
10861317020528Nellcor Oxisensor D-25
10816317020566Nellcor OxiMax MAX-N NEONATAL/ADULT
10816317020559Nellcor OxiMax MAX-I INFANT
10816317020542Nellcor OxiMax MAX-AL ADULT
10816317020535Nellcor OxiMax MAX-A ADULT
10816317020528Nellcor Oxisensor D-25

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