Catalog Number

NA

Brand Name

MCB Series

Version/Model Number

BICARD SYSTEM, MCB212-100, LG 220V/50HZ

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

-

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

-

Product Code

FIN

Product Code Name

Tank, Holding, Dialysis

Public Device Record Key

b8ed515a-90d1-4407-a83d-20d6a7336270

Public Version Date

August 31, 2018

Public Version Number

3

DI Record Publish Date

December 29, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-