Catalog Number

-

Brand Name

APK

Version/Model Number

S523-090

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"

-

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

K082846,K082846

Product Code

DQA

Product Code Name

Oximeter

Public Device Record Key

f9ab790a-ddbb-43f4-bc63-8b56c522d82a

Public Version Date

August 02, 2022

Public Version Number

1

DI Record Publish Date

July 25, 2022

Package DI Number

16946725591410

Quantity per Package

24

Contains DI Package

06946725537343

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-