Catalog Number

-

Brand Name

Nonin

Version/Model Number

8000CA

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

Yes

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

K090807,K090807,K090807

Product Code

MUD

Product Code Name

Oximeter, Tissue Saturation

Public Device Record Key

1b379307-b1fd-43e8-9446-466ac980a3fc

Public Version Date

December 01, 2020

Public Version Number

5

DI Record Publish Date

August 24, 2016

Package DI Number

00833166007688

Quantity per Package

20

Contains DI Package

00849686074147

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box