Catalog Number

-

Brand Name

COBE® Spectra

Version/Model Number

70629

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

BK020041,BK020041

Product Code

GKT

Product Code Name

Separator, automated, blood cell, diagnostic

Public Device Record Key

975038b1-02fb-4bb1-94bc-90bf5f8deb9b

Public Version Date

August 09, 2022

Public Version Number

5

DI Record Publish Date

September 15, 2016

Package DI Number

35020583706294

Quantity per Package

6

Contains DI Package

05020583706293

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-