Catalog Number

-

Brand Name

Nonin

Version/Model Number

3150 WristOx2

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"

-

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

K102350,K102350

Product Code

DQA

Product Code Name

Oximeter

Public Device Record Key

0c039f7e-0c42-4811-ac49-8a19492d4531

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

March 08, 2017

Package DI Number

00849686066951

Quantity per Package

1

Contains DI Package

00849686094657

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box