Catalog Number

ECS140

Brand Name

RUSCH

Version/Model Number

IPN054364

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

K000070,K000070,K000070,K000070

Product Code

KOD

Product Code Name

CATHETER, UROLOGICAL

Public Device Record Key

b6966664-a0a0-4540-8dbe-2ef43b97ea94

Public Version Date

January 18, 2021

Public Version Number

6

DI Record Publish Date

August 13, 2019

Package DI Number

34026704663027

Quantity per Package

10

Contains DI Package

24026704663020

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case