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

a3e2831b-5232-44b8-9cbb-59acb271ddc4

Public Version Date

April 27, 2022

Public Version Number

4

DI Record Publish Date

February 08, 2019

Package DI Number

30677964000080

Quantity per Package

12

Contains DI Package

00677964000089

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton