Catalog Number

GFTB 508

Brand Name

Gabriel Feeding Tube with Balloon

Version/Model Number

8 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

K191784,K191784

Product Code

KNT

Product Code Name

Tubes, Gastrointestinal (And Accessories)

Public Device Record Key

15e32c17-83fa-48fb-ac29-8c01ebefeee3

Public Version Date

February 26, 2020

Public Version Number

1

DI Record Publish Date

February 18, 2020

Package DI Number

10860000931332

Quantity per Package

10

Contains DI Package

00860000931335

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box