Catalog Number

EZW1-M

Brand Name

Easy@Home Pregnancy Test Midstream (20 tests kit)

Version/Model Number

EZM1-H20

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

LCX

Product Code Name

Kit, Test, Pregnancy, Hcg, Over The Counter

Public Device Record Key

c01a443c-0823-410f-b696-b0e69ba5078f

Public Version Date

July 06, 2018

Public Version Number

4

DI Record Publish Date

December 23, 2016

Package DI Number

10850253007816

Quantity per Package

56

Contains DI Package

00850253007819

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton