Catalog Number

GFTB 412

Brand Name

Gabriel Feeding Tube with Balloon

Version/Model Number

12 Fr

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Conditional

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

K160787,K160787

Product Code

KNT

Product Code Name

TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Public Device Record Key

8371329d-5db9-4c4c-acbb-b164a5e30a70

Public Version Date

February 06, 2020

Public Version Number

2

DI Record Publish Date

January 24, 2019

Package DI Number

10860000931325

Quantity per Package

10

Contains DI Package

00860000931328

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box