Catalog Number

-

Brand Name

Rika Plasma Donation System

Version/Model Number

42000

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

-

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

-

Product Code

GKT

Product Code Name

Separator, Automated, Blood Cell, Diagnostic

Public Device Record Key

a69f6807-0adb-4844-8b91-62fdf82b8498

Public Version Date

August 04, 2022

Public Version Number

2

DI Record Publish Date

July 13, 2022

Package DI Number

35020583420008

Quantity per Package

1

Contains DI Package

05020583420007

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-