Catalog Number

-

Brand Name

HAEMONETICS MCS+ (LN9000) APHERESIS SYSTEM

Version/Model Number

00980-00

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

K953681,K953681

Product Code

LKN

Product Code Name

SEPARATOR, AUTOMATED, BLOOD CELL AND PLASMA, THERAPEUTIC

Public Device Record Key

5b69761e-4327-46d2-95d3-01ac15266e8d

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

February 08, 2017

Package DI Number

30812747012076

Quantity per Package

8

Contains DI Package

10812747012072

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-