Catalog Number

-

Brand Name

APK

Version/Model Number

S543-010

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

b5dc90e4-f26d-40ae-8673-ecfffa00ab18

Public Version Date

August 02, 2022

Public Version Number

1

DI Record Publish Date

July 25, 2022

Package DI Number

16946725591403

Quantity per Package

24

Contains DI Package

06946725537282

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-