Catalog Number

-

Brand Name

VersiHD

Version/Model Number

NX1000-16

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

-

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

7926e34d-b9d1-44d4-9031-5e3d14a6a28a

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

December 22, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-