Catalog Number

-

Brand Name

Walgreens

Version/Model Number

10170

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

K172257,K172257,K172257

Product Code

LCX

Product Code Name

Kit, Test, Pregnancy, Hcg, Over The Counter

Public Device Record Key

0f692b1b-5bc8-4b89-8235-ef6e9d265218

Public Version Date

September 24, 2018

Public Version Number

1

DI Record Publish Date

August 24, 2018

Package DI Number

10311917198924

Quantity per Package

24

Contains DI Package

00311917198927

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case