Catalog Number

-

Brand Name

Aurora Plasmapheresis System Software Version 2.1

Version/Model Number

SW 2.1

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)

-

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

fe91b685-b504-4d1f-9063-f6cfda7355e1

Public Version Date

November 04, 2019

Public Version Number

1

DI Record Publish Date

October 25, 2019

Package DI Number

10810020440000

Quantity per Package

3

Contains DI Package

00810020440003

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-