Catalog Number

-

Brand Name

NX2ME APP

Version/Model Number

NX3094

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

June 01, 2021

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

-

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

FKP

Product Code Name

System, Dialysate Delivery, Single Patient

Public Device Record Key

4847dfcf-d8d8-4f36-a764-ba655a00af59

Public Version Date

June 07, 2021

Public Version Number

2

DI Record Publish Date

February 15, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-