Catalog Number

BL+A211/V804

Brand Name

NIPRO SET BLOOD TUBING SET WITH TRANSDUCER PROTECTORS AND PRIMING SET

Version/Model Number

A211/V804

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

FJK

Product Code Name

SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE

Public Device Record Key

b6dfa9d3-ab39-4a53-ac5f-957060edb151

Public Version Date

June 07, 2019

Public Version Number

3

DI Record Publish Date

September 16, 2015

Package DI Number

40383790004075

Quantity per Package

24

Contains DI Package

00383790004077

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case