Catalog Number

-

Brand Name

HAEMONETICS PCS 2 APHERESIS SYSTEM

Version/Model Number

06002-110-EXS-EW

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

-

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

BK120065

Product Code

GKT

Product Code Name

Separator, automated, blood cell, diagnostic

Public Device Record Key

a4ffc229-d615-4780-b070-b4b79947a673

Public Version Date

January 08, 2021

Public Version Number

4

DI Record Publish Date

February 08, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-