Catalog Number

-

Brand Name

Puriblood

Version/Model Number

LRW-50-12-PS

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

BK180188,BK180188

Product Code

KSR

Product Code Name

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

Public Device Record Key

c5ca7278-666b-41a6-883e-4fc27141ec1c

Public Version Date

November 19, 2020

Public Version Number

2

DI Record Publish Date

August 28, 2019

Package DI Number

14719878520000

Quantity per Package

25

Contains DI Package

04719878520003

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

carton