Catalog Number

BC30-PURE

Brand Name

PureBMC-30mL GenesisCS Component Concentrating System

Version/Model Number

BC30-PURE

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

BK050055,K024080

Product Code

JQC

Product Code Name

CENTRIFUGES (MICRO, ULTRA, REFRIGERATED) FOR CLINICAL USE

Public Device Record Key

3b4732d4-fdf2-4a32-9277-afbab191552b

Public Version Date

July 23, 2020

Public Version Number

3

DI Record Publish Date

January 08, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-