Catalog Number

-

Brand Name

Expel™ Large Capacity Drainage Catheter Connecting Tube

Version/Model Number

H7493938000150

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Safe

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

KGZ

Product Code Name

ACCESSORIES, CATHETER

Public Device Record Key

0ea5e94c-5f53-4119-b498-b23dbeaacef6

Public Version Date

August 09, 2018

Public Version Number

3

DI Record Publish Date

August 25, 2016

Package DI Number

08714729862925

Quantity per Package

5

Contains DI Package

08714729862949

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-