Catalog Number

70-0051-218

Brand Name

EndoVive Gastrostomy Tube, Straight, with ENFit Connector

Version/Model Number

M00509910

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

K142075,K142075

Product Code

PIF

Product Code Name

Gastrointestinal Tubes With Enteral Specific Connectors

Public Device Record Key

6f91d09e-8f76-4551-a149-7a92a24d7a27

Public Version Date

April 20, 2020

Public Version Number

5

DI Record Publish Date

August 02, 2016

Package DI Number

00813939023893

Quantity per Package

5

Contains DI Package

00813939023619

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case Box