Catalog Number

BL+A430/V912

Brand Name

Nipro Set Blood Tubing Set

Version/Model Number

A430/V912

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

50145193-0bf3-48a5-b3c2-fb4ea782cdd9

Public Version Date

August 03, 2020

Public Version Number

1

DI Record Publish Date

July 24, 2020

Package DI Number

40383790008806

Quantity per Package

24

Contains DI Package

00383790008808

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

case