Catalog Number

20-100

Brand Name

Kohli Catheter

Version/Model Number

20-100

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

K172422,K172422,K172422

Product Code

EZL

Product Code Name

Catheter, Retention Type, Balloon

Public Device Record Key

f348ea0e-aff5-4701-91b4-9cc0d03e93b4

Public Version Date

December 04, 2020

Public Version Number

4

DI Record Publish Date

July 02, 2019

Package DI Number

00860239001328

Quantity per Package

10

Contains DI Package

00860239001311

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Shipping Carton