Catalog Number

X6S4021USB

Brand Name

Aurora Software Version 2.1C Upgrade

Version/Model Number

Version 2.1C

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

-

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

BK190368,BK190368

Product Code

GKT

Product Code Name

Separator, Automated, Blood Cell, Diagnostic

Public Device Record Key

ddb48358-d4b5-44b0-9e3f-672bb175f07c

Public Version Date

June 17, 2021

Public Version Number

1

DI Record Publish Date

June 09, 2021

Package DI Number

10810020440307

Quantity per Package

3

Contains DI Package

00810020440300

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton