Catalog Number

-

Brand Name

CVS Health

Version/Model Number

OX200

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)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

PGJ

Product Code Name

Oximeter, Wellness

Public Device Record Key

cbbcd043-aef6-4f42-a578-304b0d394f3b

Public Version Date

November 10, 2021

Public Version Number

2

DI Record Publish Date

October 16, 2019

Package DI Number

10050428504663

Quantity per Package

48

Contains DI Package

00050428504666

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case