Catalog Number

70-0068-116

Brand Name

Gastrostomy Feeding Tube with ENFit Connector

Version/Model Number

8884720163X

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

K171347,K171347

Product Code

PIF

Product Code Name

Gastrointestinal Tubes With Enteral Specific Connectors

Public Device Record Key

0734112b-51b9-4588-a8ca-1c145bb6c308

Public Version Date

April 20, 2020

Public Version Number

5

DI Record Publish Date

January 16, 2018

Package DI Number

00813939025132

Quantity per Package

5

Contains DI Package

00813939025064

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case box