Catalog Number

JP-HUR890

Brand Name

CARDINAL HEALTH

Version/Model Number

JP-HUR890

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"

Yes

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

GBX

Product Code Name

CATHETER, IRRIGATION

Public Device Record Key

9fe96bf8-2834-446f-93a4-d409d9d492a1

Public Version Date

March 08, 2022

Public Version Number

2

DI Record Publish Date

May 27, 2020

Package DI Number

50192253022191

Quantity per Package

8

Contains DI Package

20192253022190

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE