Catalog Number

-

Brand Name

Hemocor HPH

Version/Model Number

HPH 1400

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

K923139,K923139

Product Code

KDI

Product Code Name

Dialyzer, High Permeability With Or Without Sealed Dialysate System

Public Device Record Key

ec87146b-1f97-4b33-b451-27cf70a108ea

Public Version Date

April 27, 2022

Public Version Number

5

DI Record Publish Date

September 09, 2016

Package DI Number

30677964011222

Quantity per Package

12

Contains DI Package

00677964011221

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-