Catalog Number

-

Brand Name

MomMed

Version/Model Number

HCG TEST STRIP

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

December 31, 2018

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

-

Product Code

LCX

Product Code Name

Kit, Test, Pregnancy, Hcg, Over The Counter

Public Device Record Key

9d1c0e83-23e4-4a8d-85d6-5a4acbe349f2

Public Version Date

January 31, 2019

Public Version Number

1

DI Record Publish Date

December 31, 2018

Package DI Number

36970429840110

Quantity per Package

20

Contains DI Package

06970429840119

Package Discontinue Date

December 31, 2018

Package Status

Not in Commercial Distribution

Package Type

-