Catalog Number

-

Brand Name

HAEMONETICS MCS+ (LN8150) RBC APHERESIS

Version/Model Number

00822-00

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

BK050048,BK050048

Product Code

GKT

Product Code Name

Separator, automated, blood cell, diagnostic

Public Device Record Key

9d6faaa8-9d64-42b0-b6ea-fb8e0565d0f1

Public Version Date

December 04, 2018

Public Version Number

4

DI Record Publish Date

March 20, 2017

Package DI Number

30812747013479

Quantity per Package

20

Contains DI Package

10812747013475

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-