Catalog Number

-

Brand Name

Nonin

Version/Model Number

9570

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

August 23, 2019

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

-

Product Code

DQA

Product Code Name

Oximeter

Public Device Record Key

a9bc01c1-42c1-4875-9d7e-e1fa3de6596e

Public Version Date

November 10, 2021

Public Version Number

7

DI Record Publish Date

August 24, 2016

Package DI Number

00833166001679

Quantity per Package

1

Contains DI Package

00849686074079

Package Discontinue Date

August 23, 2019

Package Status

Not in Commercial Distribution

Package Type

clamshell