Catalog Number

70-0060-114

Brand Name

Entuit Gastrostomy BR Balloon Retention Feeding Tube with ENFit Connection

Version/Model Number

SBRD-14-ENF

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

K130611,K130611

Product Code

KNT

Product Code Name

Tubes, Gastrointestinal (And Accessories)

Public Device Record Key

463f5957-600c-469e-a497-51214f0d77cd

Public Version Date

April 20, 2020

Public Version Number

5

DI Record Publish Date

August 01, 2016

Package DI Number

10827002447810

Quantity per Package

10

Contains DI Package

00827002447813

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case Box