Catalog Number

-

Brand Name

Nonin

Version/Model Number

NCell

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

April 18, 2019

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

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

DQA

Product Code Name

Oximeter

Public Device Record Key

97b871a7-d0dd-476f-8cb4-db99ac58f35c

Public Version Date

December 22, 2020

Public Version Number

3

DI Record Publish Date

September 13, 2016

Package DI Number

00849686070323

Quantity per Package

1

Contains DI Package

00833166008241

Package Discontinue Date

April 18, 2019

Package Status

Not in Commercial Distribution

Package Type

Bag