Catalog Number

-

Brand Name

Nonin

Version/Model Number

8000TW

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Safe

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

K071415,K071415

Product Code

DQA

Product Code Name

Oximeter

Public Device Record Key

a816ace7-0586-47fe-92e1-e65f9bd22d27

Public Version Date

December 01, 2020

Public Version Number

4

DI Record Publish Date

September 03, 2016

Package DI Number

00849686066234

Quantity per Package

2

Contains DI Package

00833166000818

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-