Catalog Number

PMS-130

Brand Name

Premom Pregnancy Test Strips (30 Tests)

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)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K123703,K123703,K123703

Product Code

LCX

Product Code Name

Kit, Test, Pregnancy, Hcg, Over The Counter

Public Device Record Key

a95353dd-dd4f-49d5-9ffc-7ec34b537077

Public Version Date

February 25, 2022

Public Version Number

1

DI Record Publish Date

February 17, 2022

Package DI Number

10810038632527

Quantity per Package

120

Contains DI Package

00810038632520

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton