Catalog Number

T8010

Brand Name

N/A

Version/Model Number

T8010

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

BK960043,BK960043

Product Code

KSR

Product Code Name

Container, Empty, For Collection & Processing Of Blood & Blood Components

Public Device Record Key

22493d56-354e-42c2-bddd-8cc615b9adc9

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 24, 2016

Package DI Number

00817827025532

Quantity per Package

36

Contains DI Package

00817827025037

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-