Catalog Number

-

Brand Name

Nellcor

Version/Model Number

MAX-N

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

July 31, 2019

Issuing Agency

In GS1

MRI safety Status

MR Unsafe

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K041867,K041867

Product Code

NLF

Product Code Name

Oximeter, Reprocessed

Public Device Record Key

745ece56-cf12-4973-907e-edf6c5978b22

Public Version Date

November 10, 2021

Public Version Number

5

DI Record Publish Date

September 24, 2016

Package DI Number

30817357020022

Quantity per Package

24

Contains DI Package

10817357020028

Package Discontinue Date

March 19, 2021

Package Status

Not in Commercial Distribution

Package Type

Box