Catalog Number

-

Brand Name

Well at Walgreens

Version/Model Number

Digital Pregnancy Test

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

November 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

K060128,K060128,K060128

Product Code

LCX

Product Code Name

Kit, Test, Pregnancy, Hcg, Over The Counter

Public Device Record Key

a8ba4d5e-a39e-4645-a649-3ad4b7844d41

Public Version Date

August 16, 2021

Public Version Number

4

DI Record Publish Date

August 15, 2016

Package DI Number

10311917168187

Quantity per Package

24

Contains DI Package

00311917168180

Package Discontinue Date

November 30, 2020

Package Status

Not in Commercial Distribution

Package Type

Case