Catalog Number

-

Brand Name

CAPIOX® HEMOCONCENTRATOR

Version/Model Number

CX*HC05S

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

KDI

Product Code Name

Dialyzer, High Permeability With Or Without Sealed Dialysate System

Public Device Record Key

db4d4f28-344c-47c0-99cc-5e2eaa0d8aa2

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 15, 2015

Package DI Number

54987350738337

Quantity per Package

10

Contains DI Package

04987350738332

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-