Catalog Number

PMS-130

Brand Name

Premom Pregnancy Test Strip (30 test kit)

Version/Model Number

PM1-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)

-

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

b62331e6-b0ee-4ff2-856b-4d060020fb12

Public Version Date

August 01, 2018

Public Version Number

1

DI Record Publish Date

July 01, 2018

Package DI Number

10855944007311

Quantity per Package

80

Contains DI Package

00855944007314

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton