Catalog Number

90819

Brand Name

COBE® 2991

Version/Model Number

90819

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

K760856,K760856

Product Code

GKT

Product Code Name

Separator, Automated, Blood Cell, Diagnostic

Public Device Record Key

1d3cb780-e8e3-48db-8e14-e9b0801d22fa

Public Version Date

September 01, 2022

Public Version Number

2

DI Record Publish Date

June 07, 2021

Package DI Number

35020583908193

Quantity per Package

12

Contains DI Package

05020583908192

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-