Catalog Number

70106.6547

Brand Name

NA

Version/Model Number

BC 140 Plus HEMOCONCENTRATOR

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

K123288,K123288

Product Code

KDI

Product Code Name

Dialyzer, high permeability with or without sealed dialysate system

Public Device Record Key

36302530-29d0-488a-bf25-3c3f313f0bd4

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

December 20, 2016

Package DI Number

04058863030906

Quantity per Package

10

Contains DI Package

04058863039725

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-