Catalog Number

-

Brand Name

Good Sense

Version/Model Number

69-50C

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

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K073454,K073454,K073454

Product Code

DQA

Product Code Name

Oximeter

Public Device Record Key

8b7f1990-43da-4f75-80cd-19dcb6d753b2

Public Version Date

November 10, 2021

Public Version Number

4

DI Record Publish Date

September 23, 2016

Package DI Number

10846036007692

Quantity per Package

24

Contains DI Package

30846036007696

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

MASTER CARTON