Catalog Number

-

Brand Name

Nonin

Version/Model Number

8000Q2

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

K080255,K080255

Product Code

DQA

Product Code Name

Oximeter

Public Device Record Key

bc9238f1-cfdd-49a6-8b8f-471c82eed14d

Public Version Date

November 10, 2021

Public Version Number

4

DI Record Publish Date

August 24, 2016

Package DI Number

00833166000757

Quantity per Package

1

Contains DI Package

00849686074703

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Bag