Catalog Number

HNB5.0-38-65-P-NS-KMP-URO

Brand Name

Kumpe Access Catheter

Version/Model Number

G47316

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

KOD

Product Code Name

CATHETER, UROLOGICAL

Public Device Record Key

1af96e58-6593-4bf6-9228-36ffea1f4a66

Public Version Date

April 04, 2019

Public Version Number

1

DI Record Publish Date

March 27, 2019

Package DI Number

10827002473161

Quantity per Package

5

Contains DI Package

00827002473164

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-