Premier Value - FPPL Premier Value SPS +/- - PHARMACY VALUE ALLIANCE, LLC

Duns Number:089138159

Device Description: FPPL Premier Value SPS +/-

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More Product Details

Catalog Number

-

Brand Name

Premier Value

Version/Model Number

One Step Pregnancy Test

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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

K042280,K042280,K042280

Product Code Details

Product Code

LCX

Product Code Name

Kit, Test, Pregnancy, Hcg, Over The Counter

Device Record Status

Public Device Record Key

3b217ec3-a914-40df-95c5-857c56dced0c

Public Version Date

January 31, 2019

Public Version Number

4

DI Record Publish Date

August 30, 2016

Additional Identifiers

Package DI Number

10840986016636

Quantity per Package

24

Contains DI Package

00840986016639

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Shipping Case

"PHARMACY VALUE ALLIANCE, LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 1
2 A medical device with a moderate to high risk that requires special controls. 5