Catalog Number

EZW1-S-40

Brand Name

Easy@Home Pregnancy Test Strip (40 tests kit)

Version/Model Number

EZW1-S

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

K043443,K043443,K043443

Product Code

-

Product Code Name

-

Public Device Record Key

1145f520-254f-417c-b2a6-ae23da020e07

Public Version Date

July 07, 2020

Public Version Number

1

DI Record Publish Date

June 29, 2020

Package DI Number

10810038630370

Quantity per Package

80

Contains DI Package

00810038630373

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton