Catalog Number

NELMAX-N

Brand Name

NA

Version/Model Number

NELMAX-N

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"

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

K041127,K041127

Product Code

NLF

Product Code Name

OXIMETER, REPROCESSED

Public Device Record Key

de49d933-5cc4-4eea-8af9-b6262605adb1

Public Version Date

November 10, 2021

Public Version Number

5

DI Record Publish Date

September 22, 2016

Package DI Number

20888551042113

Quantity per Package

24

Contains DI Package

10888551042116

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton