Catalog Number

-

Brand Name

DeRoyal

Version/Model Number

4-10569

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

452262d8-41b9-4d6b-8402-38eb23261533

Public Version Date

August 10, 2021

Public Version Number

4

DI Record Publish Date

September 12, 2016

Package DI Number

50749756847563

Quantity per Package

50

Contains DI Package

00749756847568

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case