Catalog Number

MAX-N

Brand Name

N/A

Version/Model Number

N/A

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

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

K042316,K042316

Product Code

NLF

Product Code Name

OXIMETER, REPROCESSED

Public Device Record Key

bef35323-c0a8-4dca-ac51-9c7063b68c9e

Public Version Date

November 10, 2021

Public Version Number

4

DI Record Publish Date

September 23, 2016

Package DI Number

50885825014327

Quantity per Package

24

Contains DI Package

00885825014322

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

case