Catalog Number

-

Brand Name

Nellcor

Version/Model Number

FLEXMAX-HC

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

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"

Yes

For Single-Use

-

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

K162014,K162014

Product Code

DQA

Product Code Name

Oximeter

Public Device Record Key

42e9dcbc-2098-4922-8698-b1f4665a2366

Public Version Date

November 10, 2021

Public Version Number

6

DI Record Publish Date

September 29, 2017

Package DI Number

10884521617469

Quantity per Package

20

Contains DI Package

20884521617466

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE