Catalog Number

X6R2350

Brand Name

Plastic Storage Container

Version/Model Number

X6R2350

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"

-

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

BK990009,BK990009,BK990009

Product Code

GKT

Product Code Name

Separator, Automated, Blood Cell, Diagnostic

Public Device Record Key

0cf629eb-f232-40c5-b95c-dfae90dc585b

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 02, 2016

Package DI Number

24086000100179

Quantity per Package

7

Contains DI Package

14086000100172

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton