Catalog Number

-

Brand Name

Nellcor

Version/Model Number

MAXN

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

Labeling does not contain MRI Safety Information

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K012891,K012891

Product Code

DQA

Product Code Name

Oximeter

Public Device Record Key

e3101889-bc54-42c5-a6cf-e010d8f4a3e5

Public Version Date

November 10, 2021

Public Version Number

5

DI Record Publish Date

September 24, 2016

Package DI Number

10884522041720

Quantity per Package

24

Contains DI Package

20884522041727

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE