Catalog Number

-

Brand Name

Nonin

Version/Model Number

3150

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

-

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

-

Product Code

DQA

Product Code Name

Oximeter

Public Device Record Key

dbd18efb-4fa9-46d9-9f9b-5fec1ce8f5ab

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 03, 2016

Package DI Number

00833166009927

Quantity per Package

1

Contains DI Package

00833166001303

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Bag