Catalog Number

-

Brand Name

Pulse Oximeter

Version/Model Number

7089

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K090599,K090599

Product Code

DQA

Product Code Name

Oximeter

Public Device Record Key

a76b4a8e-386c-4503-93ee-c456141c6882

Public Version Date

November 10, 2021

Public Version Number

4

DI Record Publish Date

September 24, 2016

Package DI Number

00616784708935

Quantity per Package

10

Contains DI Package

00616784708928

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-