Catalog Number

E3-2444, 3-2444

Brand Name

Decompression Tube

Version/Model Number

E3-2444

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

KGC

Product Code Name

Tube, Gastro-Enterostomy

Public Device Record Key

9abc50b6-98ce-4527-809a-a1a52cfc3f99

Public Version Date

April 20, 2020

Public Version Number

4

DI Record Publish Date

August 31, 2016

Package DI Number

00842071106317

Quantity per Package

10

Contains DI Package

00842071104177

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box (3-2444)