Catalog Number

70500

Brand Name

COBE® Spectra

Version/Model Number

70500

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

BK900002,BK900002

Product Code

GKT

Product Code Name

Separator, Automated, Blood Cell, Diagnostic

Public Device Record Key

ea593fdd-e9d1-43fc-b844-59fd606beb19

Public Version Date

September 01, 2022

Public Version Number

2

DI Record Publish Date

June 07, 2021

Package DI Number

35020583705006

Quantity per Package

6

Contains DI Package

05020583705005

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-