Catalog Number

-

Brand Name

Well at Walgreens

Version/Model Number

Digital Pregnancy Test

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

K060128,K060128,K060128

Product Code

LCX

Product Code Name

Kit, Test, Pregnancy, Hcg, Over The Counter

Public Device Record Key

b5d8faa2-ad82-473c-b4b4-f067656e6f3c

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

August 15, 2016

Package DI Number

10311917149216

Quantity per Package

24

Contains DI Package

00311917149219

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case