Catalog Number

-

Brand Name

Haemonetics® PCS®2 & NexSys PCS™ Systems

Version/Model Number

00620-CP

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

BK950033,BK950033

Product Code

GKT

Product Code Name

Separator, automated, blood cell, diagnostic

Public Device Record Key

dc546d21-9d18-4548-a3b1-1b84fc350d3d

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

February 16, 2018

Package DI Number

30812747011765

Quantity per Package

100

Contains DI Package

10812747011761

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-