Catalog Number

-

Brand Name

Gastrostomy Tube, 3 port, 16FR, NON-ENFit

Version/Model Number

5120

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

FPD

Product Code Name

Tube, Feeding

Public Device Record Key

3ac9b98b-f0ae-4d01-95a1-6a2602ecad9a

Public Version Date

December 25, 2020

Public Version Number

3

DI Record Publish Date

October 01, 2019

Package DI Number

00616784512037

Quantity per Package

5

Contains DI Package

00616784512013

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box