Catalog Number

-

Brand Name

Nonin

Version/Model Number

8500

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

K893221,K893221,K893221,K893221

Product Code

DQA

Product Code Name

Oximeter

Public Device Record Key

3cf24f81-f7b5-4a0f-9114-065d75f0e233

Public Version Date

November 10, 2021

Public Version Number

4

DI Record Publish Date

August 24, 2016

Package DI Number

00833166003567

Quantity per Package

1

Contains DI Package

00849686074185

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box