Catalog Number

70106.6547

Brand Name

NA

Version/Model Number

BC 60 Plus HEMOCONCENTRATOR

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

December 20, 2016

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

488b357a-6722-4efa-85ff-96e3345236a4

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

October 24, 2015

Package DI Number

04037691899305

Quantity per Package

20

Contains DI Package

04037691899299

Package Discontinue Date

December 20, 2016

Package Status

Not in Commercial Distribution

Package Type

-