Catalog Number

-

Brand Name

Hemocor HPH

Version/Model Number

HPH Junior

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

K050952,K050952

Product Code

KDI

Product Code Name

Dialyzer, High Permeability With Or Without Sealed Dialysate System

Public Device Record Key

f8860dd8-caf3-4ec6-909c-996a41142796

Public Version Date

April 27, 2022

Public Version Number

5

DI Record Publish Date

September 09, 2016

Package DI Number

30677964000868

Quantity per Package

12

Contains DI Package

00677964000867

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-