Catalog Number

-

Brand Name

HAEMONETICS MCS+ APHERESIS SYSTEM

Version/Model Number

00994-00

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

BK060057,BK060057

Product Code

GKT

Product Code Name

Separator, automated, blood cell, diagnostic

Public Device Record Key

896a8e75-2585-43e3-adb1-7a2af6f5e714

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

January 31, 2017

Package DI Number

30812747012090

Quantity per Package

8

Contains DI Package

10812747012096

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-