Catalog Number

PM1-M3-5

Brand Name

Premom Pregnancy Test Midstream(5 tests)

Version/Model Number

PM1-M3

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

K103574,K103574,K103574

Product Code

LCX

Product Code Name

Kit, Test, Pregnancy, Hcg, Over The Counter

Public Device Record Key

625e7187-c19d-4f07-ae8d-95bfb981ce57

Public Version Date

August 09, 2019

Public Version Number

1

DI Record Publish Date

August 01, 2019

Package DI Number

10850003180189

Quantity per Package

96

Contains DI Package

00850003180182

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton