Catalog Number

-

Brand Name

CVS Health

Version/Model Number

One Step Ovulation Predictor

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

December 02, 2019

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

0a5f01d2-55ee-443e-a402-195345ced05a

Public Version Date

December 03, 2019

Public Version Number

2

DI Record Publish Date

February 06, 2019

Package DI Number

10050428356378

Quantity per Package

48

Contains DI Package

00050428356371

Package Discontinue Date

December 02, 2019

Package Status

Not in Commercial Distribution

Package Type

Shipping case