Catalog Number

EZW1-S-60

Brand Name

Easy@Home Pregnancy Test (60 HCG strips)

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

LCX

Product Code Name

Kit, Test, Pregnancy, Hcg, Over The Counter

Public Device Record Key

ef27a3c6-5312-4b5d-9713-a3ea86e37778

Public Version Date

February 25, 2022

Public Version Number

1

DI Record Publish Date

February 17, 2022

Package DI Number

10810038631971

Quantity per Package

60

Contains DI Package

00810038631974

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton