Catalog Number

F5PG013.02

Brand Name

Progen PRP Advantage

Version/Model Number

TN15MLSINGLE

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"

Yes

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

PQD

Product Code Name

Blood Specimen Collection Convenience Kit (Excludes Hiv)

Public Device Record Key

b857730a-022f-4c30-8744-974fe3d353c2

Public Version Date

May 17, 2022

Public Version Number

1

DI Record Publish Date

May 09, 2022

Package DI Number

00850035498392

Quantity per Package

3

Contains DI Package

00850035498378

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Kit