Catalog Number

-

Brand Name

HAEMONETICS MCS+ (LN8150) AND RBC APHERISIS

Version/Model Number

0822F-2P

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

BK120083,BK120083

Product Code

GKT

Product Code Name

Separator, automated, blood cell, diagnostic

Public Device Record Key

bfa68b49-7163-442d-ac96-2d96680bb168

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

April 17, 2017

Package DI Number

30812747013509

Quantity per Package

8

Contains DI Package

10812747013505

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton