Catalog Number

-

Brand Name

HAEMONETICS MCS+ (LN9000) SYSTEM

Version/Model Number

994CF-CPP

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

BK050047,BK050047

Product Code

GKT

Product Code Name

Separator, automated, blood cell, diagnostic

Public Device Record Key

90a33c7e-ffc2-4b5f-9798-8f952943512e

Public Version Date

December 04, 2018

Public Version Number

4

DI Record Publish Date

February 08, 2017

Package DI Number

30812747012274

Quantity per Package

8

Contains DI Package

10812747012270

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-