Catalog Number

-

Brand Name

CVS Health

Version/Model Number

Daily Ovulation Predictor

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

April 30, 2020

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

CEP

Product Code Name

Radioimmunoassay, Luteinizing Hormone

Public Device Record Key

3d2c1d30-148a-44a9-a08c-f881691dacf7

Public Version Date

May 01, 2020

Public Version Number

2

DI Record Publish Date

February 11, 2019

Package DI Number

10050428407865

Quantity per Package

24

Contains DI Package

00050428407868

Package Discontinue Date

April 30, 2020

Package Status

Not in Commercial Distribution

Package Type

Shipping case