Catalog Number

-

Brand Name

DeRoyal

Version/Model Number

72-8000

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

KSR

Product Code Name

CONTAINER, EMPTY, FOR COLLECTION & PROCESSING OF BLOOD & BLOOD COMPONENTS

Public Device Record Key

6036cb94-3ef0-4296-988b-fa68caa2d4ea

Public Version Date

September 23, 2019

Public Version Number

3

DI Record Publish Date

September 12, 2016

Package DI Number

50749756308156

Quantity per Package

24

Contains DI Package

00749756308151

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case