Catalog Number

EZM1-H3

Brand Name

Easy@Home Pregnancy Test (3 HCG Midstreams)

Version/Model Number

EZW1-M

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,K043443

Product Code

LCX

Product Code Name

Kit, Test, Pregnancy, Hcg, Over The Counter

Public Device Record Key

24b4161e-92d2-4ac0-b5e7-31c9c3d0679c

Public Version Date

August 01, 2018

Public Version Number

1

DI Record Publish Date

July 01, 2018

Package DI Number

10855944007243

Quantity per Package

84

Contains DI Package

00855944007246

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton