Catalog Number

-

Brand Name

Unimed

Version/Model Number

S523-070

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

Labeling does not contain MRI Safety Information

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"

Yes

For Single-Use

Yes

Prescription Use (Rx)

-

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

6309a02d-3324-4306-8d7f-f2a7f0d24063

Public Version Date

November 10, 2021

Public Version Number

5

DI Record Publish Date

August 22, 2016

Package DI Number

16945664808252

Quantity per Package

24

Contains DI Package

06945664808255

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

carton box