Catalog Number

90912

Brand Name

COBE® 2991

Version/Model Number

90912

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

K893962,K893962

Product Code

LKN

Product Code Name

Separator, Automated, Blood Cell And Plasma, Therapeutic

Public Device Record Key

3e7d15ea-f7ba-4a14-98ac-40ad5da09211

Public Version Date

September 01, 2022

Public Version Number

2

DI Record Publish Date

June 07, 2021

Package DI Number

35020583909121

Quantity per Package

24

Contains DI Package

05020583909120

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-