Catalog Number

-

Brand Name

STRADIS HEALTHCARE

Version/Model Number

F5PG014.02

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

e09e7cd0-4945-4457-b282-7d211f88b632

Public Version Date

June 17, 2022

Public Version Number

3

DI Record Publish Date

February 10, 2022

Package DI Number

M752F5PG014021

Quantity per Package

30

Contains DI Package

M752F5PG014020

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE