Catalog Number

-

Brand Name

Renaflo II Hemofilter

Version/Model Number

HF 1200

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K923312,K923312

Product Code

KDI

Product Code Name

Dialyzer, High Permeability With Or Without Sealed Dialysate System

Public Device Record Key

e76a7b25-9083-493c-9755-b5b0b0297bac

Public Version Date

April 27, 2022

Public Version Number

8

DI Record Publish Date

September 16, 2016

Package DI Number

30677964059149

Quantity per Package

12

Contains DI Package

00677964059148

Package Discontinue Date

February 15, 2019

Package Status

Not in Commercial Distribution

Package Type

Carton